[{"ai_confidence":0.95,"created_at":"2026-05-30T06:16:23.146672","entity":"Revolution Medicines","event_type":"regulatory","id":"8aae8541-39be-4579-b76a-b42b674b0fd4","impact":"high","pub_date":"2025-07-23","source_url":"https://ir.revmed.com/news-releases/news-release-details/revolution-medicines-announces-fda-breakthrough-therapy-0","summary":"Revolution Medicines received FDA Breakthrough Therapy Designation for elironrasib for KRAS G12C-mutated NSCLC."},{"ai_confidence":0.8,"created_at":"2026-05-30T06:16:23.146667","entity":"FDA","event_type":"announcement","id":"313860cc-dcb2-4339-ad1f-94ea9fb6ab72","impact":"low","pub_date":"2026-03-18","source_url":"https://www.youtube.com/watch?v=-W9ioTEX0rU","summary":"FDA Commissioner discussed the agency's push to fast-track life-saving drugs and deliver faster cures."},{"ai_confidence":0.95,"created_at":"2026-05-30T06:16:23.146662","entity":"Axsome Therapeutics","event_type":"regulatory","id":"0fdcf7f9-cd86-401d-8340-ffb8f10cf51a","impact":"high","pub_date":"2026-04-30","source_url":"https://www.neurologylive.com/view/fda-action-update-april-2026-acceptance-clearance-and-complete-response-letter","summary":"The FDA approved Axsome Therapeutics' AXS-05 (Auvelity) for agitation in patients with dementia due to Alzheimer's disease."},{"ai_confidence":0.9,"created_at":"2026-05-30T06:16:23.146656","entity":"Ultragenyx","event_type":"regulatory","id":"32dd1d08-5e40-4658-aed9-634f52938531","impact":"medium","pub_date":"2026-04-30","source_url":"https://www.neurologylive.com/view/fda-action-update-april-2026-acceptance-clearance-and-complete-response-letter","summary":"The FDA accepted Ultragenyx's resubmitted BLA for UX111, a gene therapy for MPS IIIA, with a PDUFA date of Sep 19, 2026."},{"ai_confidence":0.85,"created_at":"2026-05-30T06:16:23.146650","entity":"FDA","event_type":"regulatory","id":"74ac3bfd-23e6-438a-af2d-50700a9e20c4","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.biopharmadive.com/news/fda-decisions-second-quarter-2026/701159/","summary":"The FDA lowered pivotal trial requirements, awarded more special vouchers, and spotlighted a new approval framework for rare diseases."},{"ai_confidence":0.8,"created_at":"2026-05-30T06:16:23.146645","entity":null,"event_type":"regulatory","id":"f513dbfb-21e0-4dea-aeb4-dc14ec101fcc","impact":"low","pub_date":"2026-02-28","source_url":"https://www.patsnap.com/blog/expedited-review-pathways-february-2026","summary":"82 drugs received expedited review designations (Orphan Drug, Breakthrough Therapy, Priority Review) across multiple regions."},{"ai_confidence":0.8,"created_at":"2026-05-30T06:16:23.146640","entity":"FDA","event_type":"announcement","id":"d6746594-b69c-4f63-836a-db28b7e3d825","impact":"medium","pub_date":"2026-05-31","source_url":"https://www.medtechforum.eu/newsroom/fda-breaks-new-ground-for-rare-disease-approval-pathways","summary":"The FDA is prioritizing innovative therapies for rare diseases, streamlining processes and review times."},{"ai_confidence":0.85,"created_at":"2026-05-30T06:16:23.146635","entity":"FDA","event_type":"regulatory","id":"e05ee044-8e6b-4770-a201-cb21c1714c42","impact":"medium","pub_date":"2026-01-31","source_url":"https://www.medtechforum.eu/newsroom/fda-breaks-new-ground-for-rare-disease-approval-pathways","summary":"The FDA renewed its commitment to flexibility in CMC requirements for cell and gene therapies in January 2026."},{"ai_confidence":0.85,"created_at":"2026-05-30T06:16:23.146630","entity":"FDA","event_type":"announcement","id":"f9bcd9f7-7409-4895-8caa-75612d4a2b1e","impact":"medium","pub_date":"2026-05-21","source_url":"https://www.geneonline.news/en/articles/2026/5/21/5-fda-first-in-class-approvals-in-2026-new-mechanisms-new-modalities-new-markets","summary":"The FDA approved five first-in-class drugs in the first five months of 2026, exceeding the historical average."},{"ai_confidence":0.9,"created_at":"2026-05-30T06:16:23.146625","entity":null,"event_type":"regulatory","id":"cda6b0c2-28f6-483f-9c28-52f87a064b3d","impact":"high","pub_date":"2026-05-21","source_url":"https://www.geneonline.news/en/articles/2026/5/21/5-fda-first-in-class-approvals-in-2026-new-mechanisms-new-modalities-new-markets","summary":"The FDA approved Otarmeni (lunsotogene parvec-cwha) as the first gene therapy for genetic hearing loss."},{"ai_confidence":0.8,"created_at":"2026-05-30T06:16:23.146620","entity":"FDA","event_type":"regulatory","id":"50f4a97e-9b2a-4bbe-8e0a-6911aa566f53","impact":"low","pub_date":"2026-05-31","source_url":"https://www.fda.gov/drugs/news-events-human-drugs/what-s-new-related-drugs-fda","summary":"The FDA issued several guidance documents in May, including those related to bioequivalence studies."},{"ai_confidence":0.9,"created_at":"2026-05-30T06:16:23.146614","entity":null,"event_type":"regulatory","id":"67d5d121-0876-4cb3-8982-761301ce43f4","impact":"high","pub_date":"2026-05-27","source_url":"https://www.fda.gov/drugs/news-events-human-drugs/what-s-new-related-drugs-fda","summary":"The FDA approved pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy."},{"ai_confidence":0.9,"created_at":"2026-05-30T06:16:23.146608","entity":"AstraZeneca","event_type":"regulatory","id":"89a5e23d-a2e4-41cc-844b-33b2fd0c1b53","impact":"high","pub_date":"2026-05-28","source_url":"https://www.fda.gov/drugs/news-events-human-drugs/what-s-new-related-drugs-fda","summary":"The FDA approved durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer."},{"ai_confidence":0.9,"created_at":"2026-05-30T06:16:23.146603","entity":"AstraZeneca","event_type":"regulatory","id":"e944e02a-1009-49fe-a080-614572e9513d","impact":"medium","pub_date":"2026-05-31","source_url":"https://www.thepharmaletter.com/article/fda-drug-regulation-and-approval-news","summary":"The FDA delayed a decision on AstraZeneca's camizestrant New Drug Application (NDA)."},{"ai_confidence":0.95,"created_at":"2026-05-30T06:16:23.146596","entity":"AstraZeneca, Daiichi Sankyo","event_type":"regulatory","id":"f1dfa212-61c7-4526-80e7-ad37ab3e6441","impact":"high","pub_date":"2026-05-22","source_url":"https://www.thepharmaletter.com/article/fda-drug-regulation-and-approval-news","summary":"AstraZeneca and Daiichi Sankyo received US approval for Datroway for first-line treatment of unresectable or metastatic TNBC."},{"ai_confidence":0.95,"created_at":"2026-05-30T06:16:23.146580","entity":"Gilead","event_type":"regulatory","id":"dad62686-c41d-4b2b-a4ab-3af1096e2774","impact":"high","pub_date":"2026-05-22","source_url":"https://www.pharmtech.com/view/pharmtech-s-regulatory-roundup-for-may-2026","summary":"The FDA granted accelerated approval for Gilead's Hepcludex (Bulevirtide) for chronic hepatitis delta virus (HDV) infection."},{"ai_confidence":0.9,"created_at":"2026-05-30T06:16:23.146549","entity":null,"event_type":"regulatory","id":"6144a985-3bb9-460f-991c-313160495294","impact":"high","pub_date":"2026-05-08","source_url":"https://www.pharmtech.com/view/pharmtech-s-regulatory-roundup-for-may-2026","summary":"The FDA approved Bizengri for an ultra-rare aggressive cancer in the bile ducts."},{"ai_confidence":0.9,"created_at":"2026-05-29T06:03:51.439208","entity":"FDA","event_type":"regulatory","id":"8c535f54-67c8-4cc9-aac4-3302481660cd","impact":"medium","pub_date":"2026-01-01","source_url":"https://www.pharmexec.com/view/fda-advisory-panel-vote-composition-covid-19-vaccines-2026-2027","summary":"FDA's advisory panel recommended updating COVID-19 vaccine shots to target the XFG variant for the 2026-2027 season."},{"ai_confidence":0.9,"created_at":"2026-05-29T06:03:51.439201","entity":"AstraZeneca","event_type":"regulatory","id":"5e49e637-e5d5-48de-ad8b-31a7897e81ce","impact":"medium","pub_date":"2026-01-01","source_url":"https://www.astrazeneca-us.com/content/az-us/media/press-releases/2026/US-FDA-decision-date-extended-for-SERENA-6-filing-of-camizestrant-to-enable-review-of-additional-data.html","summary":"The FDA extended the PDUFA date for AstraZeneca's camizestrant NDA review to allow for additional data submission."},{"ai_confidence":1.0,"created_at":"2026-05-29T06:03:51.439189","entity":"AbbVie, Inc.","event_type":"regulatory","id":"717f47d1-c19d-475b-b76a-55362c209ddc","impact":"high","pub_date":"2026-05-27","source_url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pivekimab-sunirine-pvzy-blastic-plasmacytoid-dendritic-cell-neoplasm-ultra-rare","summary":"The FDA approved AbbVie's pivekimab sunirine-pvzy (Decnupaz) for adults with blastic plasmacytoid dendritic cell neoplasm."},{"ai_confidence":0.8,"created_at":"2026-05-28T05:50:53.271975","entity":"Datroway","event_type":"regulatory","id":"4cb2574d-a062-4b73-b208-d9c68a6b6b07","impact":"high","pub_date":"2024-01-01","source_url":"https://www.kens5.com/article/news/health/three-fda-breakthrough-drugs-breast-cancer-san-antonio-medical-research/273-82a90643-c778-4c01-8a5f-10fae785b5c1","summary":"FDA approved Datroway for adults with triple-negative breast cancer, one of three recent breakthrough approvals."},{"ai_confidence":0.9,"created_at":"2026-05-28T05:50:53.271264","entity":"Summit Therapeutics","event_type":"regulatory","id":"82448220-3134-43f7-8015-52b078d5f75a","impact":"high","pub_date":"2026-01-01","source_url":"https://www.drugdiscoverytrends.com/beyond-pd-1-the-drugs-reshaping-cancer-treatment-at-asco-2026/","summary":"FDA accepted Summit Therapeutics' Biologics License Application (BLA) for ivonescimab in EGFR-mutated NSCLC in January 2026."},{"ai_confidence":0.9,"created_at":"2026-05-28T05:50:53.271254","entity":"Revolution Medicines","event_type":"regulatory","id":"6abfa7de-97f4-41b7-9330-af97bc765700","impact":"high","pub_date":"2026-01-01","source_url":"https://www.drugdiscoverytrends.com/beyond-pd-1-the-drugs-reshaping-cancer-treatment-at-asco-2026/","summary":"Revolution Medicines' daraxonrasib received FDA Breakthrough Therapy Designation for metastatic pancreatic cancer."},{"ai_confidence":0.9,"created_at":"2026-05-28T05:50:53.271246","entity":"Brii Biosciences Limited","event_type":"regulatory","id":"0d5799b7-6923-4ec4-ae78-b48502e44bad","impact":"high","pub_date":"2026-01-01","source_url":"https://www.biospace.com/press-releases/brii-bio-presents-late-breaking-data-from-its-phase-2-ensure-study-at-easl-congress-2026-further-supporting-the-potential-role-of-brii-179-in-achieving-durable-immunological-control-of-hbv","summary":"China's NMPA granted Breakthrough Therapy Designation to Brii Biosciences' elebsiran in May 2024."},{"ai_confidence":0.9,"created_at":"2026-05-28T05:50:53.271238","entity":"Brii Biosciences Limited","event_type":"regulatory","id":"57416a90-1601-4b0e-9477-b12d4191b2a0","impact":"high","pub_date":"2026-01-01","source_url":"https://www.biospace.com/press-releases/brii-bio-presents-late-breaking-data-from-its-phase-2-ensure-study-at-easl-congress-2026-further-supporting-the-potential-role-of-brii-179-in-achieving-durable-immunological-control-of-hbv","summary":"China's NMPA granted Breakthrough Therapy Designation to Brii Biosciences' BRII-179 for HBV in November 2023."},{"ai_confidence":0.9,"created_at":"2026-05-28T05:50:53.271229","entity":"AstraZeneca","event_type":"regulatory","id":"1e8ecce4-421c-4d95-917b-cf8a854e1ab6","impact":"medium","pub_date":"2024-01-01","source_url":"https://www.onclive.com/view/fda-extends-decision-date-for-camizestrant-in-hr-advanced-breast-cancer-with-an-emergent-esr1-mutation","summary":"FDA extended the review period for AstraZeneca's camizestrant for HR+ advanced breast cancer to assess additional data."},{"ai_confidence":0.9,"created_at":"2026-05-28T05:50:53.271214","entity":"Stemline Therapeutics (Decnupaz)","event_type":"regulatory","id":"4f1774c3-e2b1-4538-8803-9d276d079463","impact":"high","pub_date":"2024-01-01","source_url":"https://www.onclive.com/view/fda-approves-pivekimab-sunirine-for-blastic-plasmacytoid-dendritic-cell-neoplasm","summary":"FDA approved Stemline Therapeutics' pivekimab sunirine (Decnupaz) for adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN)."},{"ai_confidence":1.0,"created_at":"2026-05-27T05:33:03.761827","entity":"Vertanical","event_type":"regulatory","id":"389c72d5-a21c-4eb6-b31f-ffbe7d73be41","impact":"high","pub_date":"2024-05-26","source_url":"https://www.painmedicinenews.com/Clinical-Pain-Medicine/Article/05-26/Pain-FDA-Breakthrough-Nonopioid-Investigational-Therapy/80659","summary":"FDA granted Breakthrough Therapy designation to Vertanical's VER-01, a nonopioid investigational therapy for chronic low back pain."},{"ai_confidence":0.9,"created_at":"2026-05-26T05:21:49.386804","entity":"Egetis","event_type":"regulatory","id":"c3a165d0-2e22-40ee-ba78-6073f54e0349","impact":"medium","pub_date":"2024-01-01","source_url":"https://www.egetis.com/mfn_news/egetis-to-present-healthcare-resource-drivers-and-cost-in-mct8-deficiency-at-ispor-2026/","summary":"Egetis' tiratricol received Rare Pediatric Disease Designation (RPDD) from the FDA, potentially leading to a Priority Review Voucher."},{"ai_confidence":0.9,"created_at":"2026-05-26T05:21:49.386797","entity":"Egetis","event_type":"regulatory","id":"55aabfb5-c5f2-4aa8-9862-17d47b9dff94","impact":"medium","pub_date":"2024-01-01","source_url":"https://www.egetis.com/mfn_news/egetis-to-present-healthcare-resource-drivers-and-cost-in-mct8-deficiency-at-ispor-2026/","summary":"Egetis' tiratricol has been granted Breakthrough Therapy Designation by the FDA for MCT8 deficiency."},{"ai_confidence":0.9,"created_at":"2026-05-26T05:21:49.386790","entity":"Egetis","event_type":"regulatory","id":"8170eb3f-9b43-4542-ba5c-3c8575c19de6","impact":"medium","pub_date":"2026-09-28","source_url":"https://www.egetis.com/mfn_news/egetis-to-present-healthcare-resource-drivers-and-cost-in-mct8-deficiency-at-ispor-2026/","summary":"The FDA has set a PDUFA target action date of September 28, 2026, for Egetis' Emcitate\u00ae (tiratricol) for MCT8 deficiency."},{"ai_confidence":0.9,"created_at":"2026-05-26T05:21:49.386783","entity":"Egetis","event_type":"regulatory","id":"1b172e27-3d3c-4a24-8f7d-73f64a41360e","impact":"medium","pub_date":"2024-01-01","source_url":"https://www.egetis.com/mfn_news/egetis-to-present-healthcare-resource-drivers-and-cost-in-mct8-deficiency-at-ispor-2026/","summary":"Egetis' NDA for Emcitate\u00ae (tiratricol) for MCT8 deficiency has been granted Priority Review by the FDA."},{"ai_confidence":0.9,"created_at":"2026-05-26T05:21:49.386775","entity":"Egetis","event_type":"regulatory","id":"755b073c-98e4-4a14-928e-a1d2264aff58","impact":"medium","pub_date":"2024-01-01","source_url":"https://www.egetis.com/mfn_news/egetis-to-present-healthcare-resource-drivers-and-cost-in-mct8-deficiency-at-ispor-2026/","summary":"Egetis' New Drug Application (NDA) for Emcitate\u00ae (tiratricol) for MCT8 deficiency has been accepted for filing by the FDA."},{"ai_confidence":0.9,"created_at":"2026-05-26T05:21:49.386768","entity":"BeOne Medicines","event_type":"regulatory","id":"a66e5b87-2136-4bcf-950c-d72033a12534","impact":"medium","pub_date":"2024-01-01","source_url":"https://www.marketbeat.com/stocks/NASDAQ/ONC/fda-events/","summary":"BeOne Medicines' New Drug Application (NDA) for sonrotoclax for R/R MCL was accepted by the FDA and granted Priority Review."},{"ai_confidence":0.9,"created_at":"2026-05-26T05:21:49.386757","entity":"BeOne Medicines","event_type":"regulatory","id":"622ac28c-6afb-4860-92ed-b308f0e58f76","impact":"medium","pub_date":"2024-01-01","source_url":"https://www.marketbeat.com/stocks/NASDAQ/ONC/fda-events/","summary":"BeOne Medicines' sonrotoclax received FDA Breakthrough Therapy Designation for relapsed or refractory mantle cell lymphoma."},{"ai_confidence":0.9,"created_at":"2026-05-26T05:21:49.386743","entity":"BeOne Medicines","event_type":"regulatory","id":"d6586e39-1432-49b8-a0ea-261a4de79be9","impact":"high","pub_date":"2024-01-01","source_url":"https://www.marketbeat.com/stocks/NASDAQ/ONC/fda-events/","summary":"BeOne Medicines received FDA accelerated approval for BEQALZI\u2122 (sonrotoclax) to treat relapsed or refractory mantle cell lymphoma."},{"ai_confidence":0.8,"created_at":"2026-05-25T04:46:43.000473","entity":"FDA","event_type":"regulatory","id":"2573e932-a721-47b3-857a-24d4db7616d1","impact":"medium","pub_date":"2018-01-01","source_url":"https://www.drugs.com/news/fda-accelerates-action-treatments-serious-mental-illness-following-executive-order-129800.html","summary":"FDA is accelerating actions for serious mental illness treatments, prioritizing Breakthrough Therapy designated therapies, following an Executive Order."},{"ai_confidence":0.9,"created_at":"2026-05-25T04:46:43.000439","entity":"BeOne Medicines","event_type":"regulatory","id":"ea9dad3d-c199-45b0-a228-b7c25a6dd6bf","impact":"high","pub_date":"2026-05-31","source_url":"https://www.geneonline.com/5-fda-first-in-class-approvals-in-2026-new-mechanisms-new-modalities-new-markets/","summary":"FDA granted accelerated approval to BeOne Medicines' Beqalzi (sonrotoclax) for relapsed or refractory mantle cell lymphoma."},{"ai_confidence":0.9,"created_at":"2026-05-25T04:46:43.000427","entity":"AstraZeneca","event_type":"regulatory","id":"a308d4bd-0f19-44f9-b9e3-c8cb73c66c8a","impact":"high","pub_date":"2026-05-31","source_url":"https://www.geneonline.com/5-fda-first-in-class-approvals-in-2026-new-mechanisms-new-modalities-new-markets/","summary":"FDA approved AstraZeneca's Baxfendy (baxdrostat) as the first aldosterone synthase inhibitor for hypertension treatment."},{"ai_confidence":0.9,"created_at":"2026-05-25T04:46:43.000356","entity":"Bayer","event_type":"regulatory","id":"75160487-bc5a-44a7-ae42-0b605eaa7995","impact":"high","pub_date":"2024-01-01","source_url":"https://www.neurologylive.com/view/fda-accepts-nda-asundexian-dysport-noninferior-botox-safety-profile-gmg-bridging-gaps-discussion","summary":"FDA accepted Bayer's New Drug Application (NDA) for asundexian and granted it Priority Review for stroke prevention."},{"ai_confidence":0.95,"created_at":"2026-05-24T04:32:38.620360","entity":"daraxonrasib","event_type":"regulatory","id":"0797d0c7-475d-47c6-806d-26314607abc4","impact":"high","pub_date":"2025-06-27","source_url":"https://cancerletter.com/drugs-and-targets/20250627_9b/","summary":"FDA granted Breakthrough Therapy designation for daraxonrasib for the treatment of pancreatic cancer."},{"ai_confidence":0.9,"created_at":"2026-05-24T04:32:38.620351","entity":"ASPE","event_type":"announcement","id":"fb254ebb-d6bd-4038-93ac-9c903c53e089","impact":"low","pub_date":"2024-08-20","source_url":"https://aspe.hhs.gov/reports/fda-breakthrough-therapy-designation-reduced-late-stage-drug-development-time","summary":"ASPE published an abstract on how FDA's breakthrough therapy designation reduced late-stage drug development time."},{"ai_confidence":0.85,"created_at":"2026-05-24T04:32:38.620343","entity":"Jefferies","event_type":"announcement","id":"c4a70de5-c6a7-4649-8bb1-6d8d266b9013","impact":"low","pub_date":"2024-05-20","source_url":"https://trial.medpath.com/news/fda-breakthrough-therapy-designation-shows-72-approval-success-rate-in-decade-long-analysis","summary":"A Jefferies analysis found 72% of FDA breakthrough therapy designated drugs from 2013-2022 ultimately received approval."},{"ai_confidence":0.95,"created_at":"2026-05-24T04:32:38.620334","entity":"HYRNUO (sevabertinib)","event_type":"regulatory","id":"207e4010-f876-478b-a2e5-7d8a4c49fc79","impact":"high","pub_date":"2026-05-16","source_url":"https://www.businesswire.com/news/home/20260516903236/en/U.S.-FDA-Grants-Priority-Review-to-Supplemental-New-Drug-Application-for-HYRNUO-sevabertinib-Under-Investigation-as-a-First-Line-Treatment-of-HER2-Mutated-Non-Small-Cell-Lung-Cancer","summary":"FDA granted Priority Review to a sNDA for HYRNUO (sevabertinib) as a first-line treatment for HER2-mutated NSCLC."},{"ai_confidence":0.9,"created_at":"2026-05-24T04:32:38.620298","entity":"Dysport","event_type":"product","id":"aa1bd389-70a9-486f-b863-2cdfc9f7ea7b","impact":"medium","pub_date":"2024-05-20","source_url":"https://www.neurologylive.com/view/fda-accepts-nda-for-asundexian-dysport-noninferior-botox-in-safety-profile-gmg-bridging-the-gaps-discussion","summary":"New data from the phase 4 DIRECTION trial showed Dysport's noninferior safety profile to Botox for upper limb spasticity."},{"ai_confidence":0.95,"created_at":"2026-05-24T04:32:38.620281","entity":"Bayer","event_type":"regulatory","id":"e15daceb-0d1f-4da1-b162-c06cc6c46297","impact":"high","pub_date":"2024-05-20","source_url":"https://www.neurologylive.com/view/fda-accepts-nda-for-asundexian-dysport-noninferior-botox-in-safety-profile-gmg-bridging-the-gaps-discussion","summary":"FDA accepted Bayer's NDA for asundexian, an oral FXIa inhibitor, and granted Priority Review for stroke prevention."},{"ai_confidence":1.0,"created_at":"2026-05-23T04:17:21.634430","entity":"Bayer","event_type":"regulatory","id":"ad2b2cbd-b402-41c0-b1fd-c3fcbbedaac0","impact":"medium","pub_date":"2025-11-01","source_url":"https://www.bayer.com/en/us/news-stories/new-drug-application-for-hyrnuo","summary":"HYRNUO received accelerated approval in November 2025 for locally advanced or metastatic HER2 TKD mutated NSCLC."},{"ai_confidence":1.0,"created_at":"2026-05-23T04:17:21.634423","entity":"Bayer","event_type":"regulatory","id":"e27ef132-6985-4e86-94f7-ce9ce1b21659","impact":"high","pub_date":"2024-01-01","source_url":"https://www.bayer.com/en/us/news-stories/new-drug-application-for-hyrnuo","summary":"FDA granted Priority Review to Bayer's sNDA for HYRNUO (sevabertinib) as a first-line treatment for HER2-mutated NSCLC."},{"ai_confidence":0.9,"created_at":"2026-05-23T04:17:21.634415","entity":"Belite Bio","event_type":"regulatory","id":"89c9b237-f5d6-40bb-a816-f9e4f72d26e8","impact":"low","pub_date":"2024-01-01","source_url":"https://markets.businessinsider.com/news/stocks/belite-bio-receives-orphan-drug-status-for-tinlarebant-in-stargardt-disease-in-switzerland-1036173092","summary":"Belite Bio's tinlarebant previously received Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug Designations in the U.S."},{"ai_confidence":1.0,"created_at":"2026-05-23T04:17:21.634407","entity":"Belite Bio","event_type":"regulatory","id":"918d0953-6e59-4a6f-87d5-2d55ddfae052","impact":"high","pub_date":"2026-03-31","source_url":"https://markets.businessinsider.com/news/stocks/belite-bio-receives-orphan-drug-status-for-tinlarebant-in-stargardt-disease-in-switzerland-1036173092","summary":"Belite Bio initiated a rolling NDA submission with the FDA for tinlarebant, expected to complete in Q2 2026."},{"ai_confidence":1.0,"created_at":"2026-05-23T04:17:21.634399","entity":"Belite Bio","event_type":"regulatory","id":"b2c43898-8178-491b-884b-068dd5bf5577","impact":"medium","pub_date":"2024-01-01","source_url":"https://markets.businessinsider.com/news/stocks/belite-bio-receives-orphan-drug-status-for-tinlarebant-in-stargardt-disease-in-switzerland-1036173092","summary":"Belite Bio's tinlarebant received Orphan Drug Status from Swissmedic for Stargardt disease (STGD1)."},{"ai_confidence":1.0,"created_at":"2026-05-23T04:17:21.634391","entity":"Bristol Myers Squibb","event_type":"regulatory","id":"59322e71-ae8f-49e3-9427-a5d9e4cc6aa4","impact":"high","pub_date":"2026-02-01","source_url":"https://www.delveinsight.com/blog/emerging-multiple-myeloma-therpies-in-clinical-trials","summary":"FDA accepted BMS's NDA for iberdomide for RRMM, granting Breakthrough Therapy Designation and Priority Review, with a PDUFA date of August 17, 2026."},{"ai_confidence":0.9,"created_at":"2026-05-23T04:17:21.634384","entity":"Bayer","event_type":"regulatory","id":"2123d29f-e4cb-4ebd-9ff6-db12ead34663","impact":"low","pub_date":"2023-01-01","source_url":"https://www.neurologylive.com/view/fda-grants-priority-review-bayer-asundexian-secondary-stroke-prevention","summary":"Bayer's asundexian was previously granted Fast Track designation in 2023 for secondary stroke prevention."},{"ai_confidence":1.0,"created_at":"2026-05-23T04:17:21.634376","entity":"Bayer","event_type":"regulatory","id":"66f0ace3-14c2-4207-932c-e601df90923b","impact":"high","pub_date":"2024-01-01","source_url":"https://www.neurologylive.com/view/fda-grants-priority-review-bayer-asundexian-secondary-stroke-prevention","summary":"FDA accepted Bayer's NDA for asundexian and granted Priority Review for secondary stroke prevention."},{"ai_confidence":0.9,"created_at":"2026-05-23T04:17:21.634367","entity":"Belite Bio","event_type":"regulatory","id":"045208da-2435-4a59-83db-6b7b40ebcca9","impact":"medium","pub_date":"2026-03-31","source_url":"https://www.quiverquant.com/news/Belite+Bio+Initiates+NDA+Submission+for+Tinlarebant+in+Stargardt+Disease+Type+1,+Reports+Q1+2026+Financial+Results","summary":"Belite Bio's tinlarebant received Breakthrough Therapy and Fast Track designations, expediting its development and review."},{"ai_confidence":1.0,"created_at":"2026-05-23T04:17:21.634358","entity":"Belite Bio","event_type":"regulatory","id":"665581d6-f9fe-45a8-96cd-e8a038e646b2","impact":"high","pub_date":"2026-03-31","source_url":"https://www.quiverquant.com/news/Belite+Bio+Initiates+NDA+Submission+for+Tinlarebant+in+Stargardt+Disease+Type+1,+Reports+Q1+2026+Financial+Results","summary":"Belite Bio initiated a rolling NDA submission to the FDA for tinlarebant for Stargardt disease type 1, expected to complete in Q2 2026."},{"ai_confidence":0.9,"created_at":"2026-05-23T04:17:21.634347","entity":"Achieve Life Sciences","event_type":"regulatory","id":"a1919d0e-3353-47db-96d6-7d9dd00e48e3","impact":"medium","pub_date":"2025-09-01","source_url":"https://www.stocktitan.net/news/ACHV/achieve-life-sciences-presents-safety-data-from-52-weeks-of-u4zjybxlwjvk.html","summary":"FDA granted Breakthrough Therapy designation to Achieve Life Sciences' cytisinicline for e-cigarette or vaping cessation."},{"ai_confidence":1.0,"created_at":"2026-05-23T04:17:21.634330","entity":"Achieve Life Sciences","event_type":"regulatory","id":"1647a39f-7488-47c9-9e26-64400518d261","impact":"high","pub_date":"2025-09-01","source_url":"https://www.stocktitan.net/news/ACHV/achieve-life-sciences-presents-safety-data-from-52-weeks-of-u4zjybxlwjvk.html","summary":"FDA accepted Achieve Life Sciences' NDA for cytisinicline for nicotine dependence, setting a PDUFA date of June 20, 2026."},{"ai_confidence":0.95,"created_at":"2026-05-22T04:00:25.015353","entity":"Bayer","event_type":"regulatory","id":"074bdf77-a2b1-4ab4-9d3f-698fb22a4f34","impact":"high","pub_date":"2026-05-18","source_url":"https://www.morningstar.com/news/business-wire/20260518787299/bayer-granted-priority-review-by-us-fda-for-asundexian-in-patients-after-a-non-cardioembolic-ischemic-stroke-or-transient-ischemic-attack","summary":"FDA granted Priority Review for Bayer's asundexian NDA for preventing secondary stroke, based on positive Phase III results."},{"ai_confidence":0.95,"created_at":"2026-05-20T03:30:24.089294","entity":"Bayer","event_type":"regulatory","id":"e6b85aa6-7dc7-467a-aef6-4627e1e82df5","impact":"medium","pub_date":"2024-05-20","source_url":"https://www.biospace.com/press-releases/bayer-granted-priority-review-by-u-s-fda-for-asundexian-in-patients-after-a-non-cardioembolic-ischemic-stroke-or-transient-ischemic-attack","summary":"FDA granted Priority Review to Bayer's New Drug Application for asundexian for secondary stroke prevention after a non-cardioembolic ischemic stroke or TIA."},{"ai_confidence":0.98,"created_at":"2026-05-20T03:30:24.089284","entity":"Daiichi Sankyo, Inc.","event_type":"regulatory","id":"4984ba36-6cdd-4695-80e6-2a4259b91091","impact":"high","pub_date":"2026-05-15","source_url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-two-separate-indications-fam-trastuzumab-deruxtecan-nxki-her2-positive-early-stage","summary":"FDA approved Daiichi Sankyo's Enhertu (fam-trastuzumab deruxtecan-nxki) for two new indications in HER2-positive early-stage breast cancer."},{"ai_confidence":0.95,"created_at":"2026-05-20T03:30:24.089243","entity":"Vertanical","event_type":"regulatory","id":"68f39279-e112-4763-b6f2-c09f38283203","impact":"medium","pub_date":"2024-05-20","source_url":"https://mgmagazine.com/press-releases/fda-grants-breakthrough-therapy-designation-to-cannabinoid-based-treatment/","summary":"FDA granted Breakthrough Therapy Designation to Vertanical's investigational cannabinoid-based treatment, VER-01, for chronic low back pain."},{"ai_confidence":1.0,"created_at":"2026-05-19T03:17:06.995314","entity":"FDA","event_type":"regulatory","id":"3c8395be-4ab7-42ca-8fe0-a891aad102a2","impact":"high","pub_date":"2026-05-15","source_url":"https://cancerletter.com/clinical/20260515_2/","summary":"FDA appears to be reversing its stance on flavored e-cigarettes, potentially allowing major tobacco companies into the fruit-flavored vape market."},{"ai_confidence":1.0,"created_at":"2026-05-19T03:17:06.995289","entity":"Bayer","event_type":"announcement","id":"a6f2fa9a-34d6-4ba5-be54-64fe61286c8f","impact":"medium","pub_date":"2024-05-20","source_url":"https://www.itnonline.com/content/bayer-announces-positive-data-investigational-pet-radiotracer","summary":"Bayer announced positive Phase III results for its investigational PET radiotracer I 124 evuzamitide for diagnosing cardiac amyloidosis."},{"ai_confidence":1.0,"created_at":"2026-05-19T03:17:06.994570","entity":"Developer of Trastuzumab Deruxtecan (Enhertu)","event_type":"regulatory","id":"1a7de97d-caac-4a25-b43e-3456e7cf97f4","impact":"high","pub_date":"2024-05-20","source_url":"https://www.oncologynewscentral.com/drugs/info/fda-approves-first-early-stage-breast-cancer-indications-for-trastuzumab-deruxtecan","summary":"FDA approved trastuzumab deruxtecan (Enhertu) for two new indications in adults with HER2-positive early-stage breast cancer."},{"ai_confidence":1.0,"created_at":"2026-05-19T03:17:06.994561","entity":"Viatris","event_type":"regulatory","id":"232f5474-6d7e-46f3-8d31-1377c7ca9257","impact":"medium","pub_date":"2024-05-20","source_url":"https://firstwordpharma.com/story/7445076","summary":"FDA accepted Viatris' New Drug Application (NDA) for fast-acting meloxicam for moderate-to-severe acute pain."},{"ai_confidence":1.0,"created_at":"2026-05-19T03:17:06.994553","entity":"BeOne Medicines","event_type":"regulatory","id":"b29bd107-4bd0-4214-bf16-246be3e083fd","impact":"high","pub_date":"2024-05-20","source_url":"https://www.stocktitan.net/news/ONC/be-one-medicines-beqalzitm-sonrotoclax-approved-by-u-s-fda-as-first-lv4r08s14zx6.html","summary":"BeOne Medicines' BEQALZI\u2122 (sonrotoclax) received FDA accelerated approval for relapsed or refractory mantle cell lymphoma."},{"ai_confidence":1.0,"created_at":"2026-05-19T03:17:06.994544","entity":"Revolution Medicines","event_type":"regulatory","id":"43bd31f5-e37f-4a90-b0c4-23026f977762","impact":"medium","pub_date":"2024-05-20","source_url":"https://www.reed.edu/newsroom/stories/2026/reed-alums-decades-long-pursuit-of-the-undruggable-is-paying-off.html","summary":"Revolution Medicines' daraxonrasib received FDA Breakthrough Therapy Designation for advanced pancreatic cancer, based on promising Phase 3 data."},{"ai_confidence":1.0,"created_at":"2026-05-19T03:17:06.994536","entity":"Developer of VER-01","event_type":"regulatory","id":"0a8ef240-e473-4b90-9c2d-f77ae286e219","impact":"medium","pub_date":"2024-05-20","source_url":"https://www.reddit.com/r/TLRY/comments/1tgmllk/fda_grants_breakthrough_therapy_status_to/","summary":"FDA granted Breakthrough Therapy Designation to VER-01, a cannabis-derived investigational treatment for chronic low back pain."},{"ai_confidence":1.0,"created_at":"2026-05-19T03:17:06.994527","entity":"Belite Bio","event_type":"regulatory","id":"6455048a-6738-4272-90a3-51d9a6d2b56f","impact":"medium","pub_date":"2024-05-20","source_url":"https://www.biospace.com/press-releases/belite-bio-receives-orphan-drug-status-for-tinlarebant-in-stargardt-disease-in-switzerland","summary":"Belite Bio received Swissmedic orphan drug status for tinlarebant for Stargardt disease, adding to existing US, EU, and Japan designations."},{"ai_confidence":1.0,"created_at":"2026-05-19T03:17:06.994517","entity":"Developer of Emi-Le (XMT-1660)","event_type":"regulatory","id":"c44d5481-be45-4202-9e63-e2bd2ac4749d","impact":"medium","pub_date":"2024-05-20","source_url":"https://www.onclive.com/view/fda-grants-breakthrough-therapy-designation-to-emi-le-for-adenoid-cystic-carcinoma","summary":"FDA granted Breakthrough Therapy Designation to emiltatug ledadotin (Emi-Le; XMT-1660) for advanced adenoid cystic carcinoma."},{"ai_confidence":1.0,"created_at":"2026-05-19T03:17:06.994502","entity":"AstraZeneca","event_type":"regulatory","id":"91e297d8-b250-4543-99eb-419a1a9e117f","impact":"high","pub_date":"2024-05-20","source_url":"https://www.biopharmadive.com/news/astrazeneca-baxfendy-approval-hypertension-blood-pressure/820491/","summary":"FDA approved AstraZeneca's Baxfendy (baxdrostat), a first-in-class aldosterone synthase inhibitor, for treating hypertension."},{"ai_confidence":0.9,"created_at":"2026-05-18T03:00:53.340213","entity":"decitabine and cedazuridine with venetoclax","event_type":"regulatory","id":"7e78772e-193e-4c4d-b781-d9853e97eb9b","impact":"medium","pub_date":"2023-10-27","source_url":"https://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs","summary":"FDA approved an oral combination of decitabine and cedazuridine tablets with venetoclax for newly diagnosed acute myeloid leukemia."},{"ai_confidence":0.9,"created_at":"2026-05-18T03:00:53.340187","entity":"atezolizumab","event_type":"regulatory","id":"f4361d10-4ecb-4ac7-8676-df55d9f6ff1b","impact":"medium","pub_date":"2023-10-27","source_url":"https://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs","summary":"FDA approved atezolizumab for adjuvant treatment of muscle-invasive bladder cancer with molecular residual disease."},{"ai_confidence":0.85,"created_at":"2026-05-18T03:00:53.339603","entity":"Jefferies","event_type":"announcement","id":"f3351ba9-d9f3-4e62-a5f8-5de370560a8f","impact":"low","pub_date":"2023-10-27","source_url":"https://www.biospace.com/article/nearly-three-quarters-of-fda-breakthrough-designated-drugs-win-approval/","summary":"A Jefferies report found 72% of FDA breakthrough therapy designated drugs between 2013-2022 were subsequently approved."},{"ai_confidence":0.95,"created_at":"2026-05-18T03:00:53.339595","entity":"AstraZeneca","event_type":"regulatory","id":"1225680d-70ff-466f-98e4-529332992016","impact":"medium","pub_date":"2023-10-27","source_url":"https://www.pharmexec.com/view/pharmaceutical-executive-daily-fda-approves-astrazeneca-s-fasenra","summary":"FDA approved AstraZeneca's Fasenra (benralizumab) for treating hypereosinophilic syndrome (HES), expanding its indication."},{"ai_confidence":0.9,"created_at":"2026-05-18T03:00:53.339586","entity":"Immgolis (golimumab-sldi)","event_type":"regulatory","id":"3eb8342a-e628-462e-8f4d-2777ebe3c2b3","impact":"medium","pub_date":"2023-10-27","source_url":"https://www.pharmaletter.com/article/fda-drug-regulation-and-approval-news","summary":"FDA approved Immgolis (golimumab-sldi) as an interchangeable biosimilar to Simponi for rheumatoid arthritis and ulcerative colitis."},{"ai_confidence":0.95,"created_at":"2026-05-18T03:00:53.339577","entity":"fam-trastuzumab deruxtecan-nxki (Enhertu)","event_type":"regulatory","id":"09cf695d-0b13-4df9-b8b8-6cc3c58a19d0","impact":"medium","pub_date":"2023-10-27","source_url":"https://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs","summary":"FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu) for two indications in HER2-positive early-stage breast cancer."},{"ai_confidence":0.9,"created_at":"2026-05-18T03:00:53.339566","entity":"Idvynso (doravirine and islatravir)","event_type":"regulatory","id":"617a6a77-8c9c-40f7-a878-b01c02e11653","impact":"medium","pub_date":"2023-10-27","source_url":"https://www.drugs.com/new-drug-approvals.html","summary":"FDA approved Idvynso (doravirine and islatravir) for the treatment of HIV-1 infection in adults."},{"ai_confidence":0.9,"created_at":"2026-05-18T03:00:53.339558","entity":"Yuviwel (navepegritide)","event_type":"regulatory","id":"d7f891fe-43cd-4306-b806-8edb67a9b2e2","impact":"medium","pub_date":"2023-10-27","source_url":"https://www.drugs.com/new-drug-approvals.html","summary":"FDA granted accelerated approval to Yuviwel (navepegritide) for children with achondroplasia."},{"ai_confidence":0.9,"created_at":"2026-05-18T03:00:53.339547","entity":"Otarmeni (lunsotogene parvec-cwha)","event_type":"regulatory","id":"4053c2d7-34e8-42e7-9b29-8a4c0d02c05d","impact":"medium","pub_date":"2023-10-27","source_url":"https://www.drugs.com/new-drug-approvals.html","summary":"FDA approved Otarmeni (lunsotogene parvec-cwha) for intracochlear infusion."},{"ai_confidence":0.9,"created_at":"2026-05-18T03:00:53.339508","entity":"Langlara (insulin glargine-aldy)","event_type":"regulatory","id":"9b6ab83b-2605-46d6-845c-f8b39b9a64ed","impact":"medium","pub_date":"2023-10-27","source_url":"https://www.drugs.com/new-drug-approvals.html","summary":"FDA approved Langlara (insulin glargine-aldy) as an interchangeable biosimilar to Lantus for diabetes treatment."},{"ai_confidence":0.9,"created_at":"2026-05-18T03:00:53.339462","entity":"sonrotoclax (Beqalzi)","event_type":"regulatory","id":"a36f9f17-2ca5-4e0c-ad5c-caf142d97c3f","impact":"medium","pub_date":"2023-10-27","source_url":"https://www.drugs.com/new-drug-approvals.html","summary":"FDA granted accelerated approval to sonrotoclax (Beqalzi) for relapsed or refractory mantle cell lymphoma."},{"ai_confidence":0.85,"created_at":"2026-05-17T02:46:38.826150","entity":"Novo Nordisk","event_type":"regulatory","id":"820d3f41-cc36-4e79-81c3-f3b7db669795","impact":"medium","pub_date":"2024-05-09","source_url":"https://www.milliman.com/en/insight/4-pending-fda-approvals-payers-pbms-market-access-teams","summary":"Novo Nordisk filed an NDA for CagriSema for adults with obesity or overweight with comorbidity in December 2025."},{"ai_confidence":0.9,"created_at":"2026-05-17T02:46:38.826141","entity":"Praxis Precision Medicines","event_type":"regulatory","id":"583f0f7b-0234-4fb5-81ce-5530e36f6af5","impact":"medium","pub_date":"2024-05-09","source_url":"https://www.milliman.com/en/insight/4-pending-fda-approvals-payers-pbms-market-access-teams","summary":"Praxis submitted an NDA for ulixacaltamide for essential tremor in February."},{"ai_confidence":0.95,"created_at":"2026-05-17T02:46:38.826133","entity":"Praxis Precision Medicines","event_type":"regulatory","id":"82775cb9-b482-48f7-9d78-dfb8fa523a61","impact":"high","pub_date":"2024-05-15","source_url":"https://www.stocktitan.net/sec-filings/PRAX/8-k-praxis-precision-medicines-inc-reports-material-event-0b22560980b3.html","summary":"FDA accepted Praxis' relutrigine NDA with priority review for SCN2A and SCN8A DEEs, with a PDUFA date of September 27, 2026."},{"ai_confidence":0.8,"created_at":"2026-05-17T02:46:38.826121","entity":"Praxis Precision Medicines","event_type":"regulatory","id":"f47fda94-0864-4b85-96ad-1fc8455cb569","impact":"high","pub_date":"2024-05-15","source_url":"https://www.stocktitan.net/sec-filings/PRAX/8-k-praxis-precision-medicines-inc-reports-material-event-0b22560980b3.html","summary":"Praxis' ulixacaltamide was granted FDA Breakthrough Therapy Designation in December 2025 for essential tremor."},{"ai_confidence":0.95,"created_at":"2026-05-17T02:46:38.826077","entity":"Praxis Precision Medicines","event_type":"regulatory","id":"94f172eb-233e-437b-97ff-c02536f13f12","impact":"high","pub_date":"2024-05-15","source_url":"https://www.stocktitan.net/sec-filings/PRAX/8-k-praxis-precision-medicines-inc-reports-material-event-0b22560980b3.html","summary":"FDA accepted Praxis' NDA for ulixacaltamide for essential tremor, setting a PDUFA target action date of January 29, 2027."},{"ai_confidence":0.9,"created_at":"2026-05-16T02:30:54.071676","entity":"Wave","event_type":"regulatory","id":"e0f43812-5986-4067-a094-d95d403b82ad","impact":"medium","pub_date":"2026-05-14","source_url":"https://www.globenewswire.com/news-release/2026/05/14/3295246/0/en/oligonucleotides-clinical-trial-drug-development-pipeline-expands-with-contributions-from-200-key-companies-delveinsight.html","summary":"Wave's Sapablursen previously received FDA Fast Track, orphan drug, and Breakthrough Therapy designations."},{"ai_confidence":0.9,"created_at":"2026-05-16T02:30:54.071668","entity":"Wave","event_type":"announcement","id":"1ce85ab6-d3e1-4097-9425-5535f367ccc5","impact":"low","pub_date":"2026-05-14","source_url":"https://www.globenewswire.com/news-release/2026/05/14/3295246/0/en/oligonucleotides-clinical-trial-drug-development-pipeline-expands-with-contributions-from-200-key-companies-delveinsight.html","summary":"Wave announced its intention to file a New Drug Application (NDA) in 2026 for accelerated approval of WVE-N531."},{"ai_confidence":0.95,"created_at":"2026-05-16T02:30:54.071659","entity":"FDA","event_type":"regulatory","id":"65d25289-ff22-4b54-a264-c9cee4ed873d","impact":"medium","pub_date":"2026-04-28","source_url":"https://www.medscape.com/viewarticle/fda-psychiatry-roundup-april-2026-2026a1000fqf","summary":"The FDA granted Breakthrough Device designation to the mRNA Gene Biomarker blood-based assay for distinguishing schizophrenia and bipolar disorder I."},{"ai_confidence":0.95,"created_at":"2026-05-16T02:30:54.071644","entity":"DemeRx","event_type":"regulatory","id":"60d82e33-f29d-430a-969a-e3bc21a87383","impact":"medium","pub_date":"2026-04-23","source_url":"https://www.medscape.com/viewarticle/fda-psychiatry-roundup-april-2026-2026a1000fqf","summary":"DemeRx's investigational new drug application (NDA) for oral noribogaine (DMX-1001) was accepted by the FDA on April 23, 2026."},{"ai_confidence":0.95,"created_at":"2026-05-15T02:16:23.759471","entity":"Adverum Biotechnologies","event_type":"regulatory","id":"737301b8-86d7-4e46-80fc-c46c738dec3b","impact":"medium","pub_date":"2026-05-14","source_url":"https://www.globenewswire.com/news-release/2026/05/14/3250349/0/en/Oligonucleotides-Clinical-Trial-Drug-Development-Pipeline-Expands-with-Contributions-from-200-Key-Companies-DelveInsight.html","summary":"ADX-324 was granted Orphan Drug Designation by the FDA for hereditary angioedema."},{"ai_confidence":0.95,"created_at":"2026-05-15T02:16:23.759464","entity":"Sanofi Genzyme","event_type":"regulatory","id":"c3c91c9b-1747-4ae2-8d18-1a5873d654c4","impact":"medium","pub_date":"2026-05-14","source_url":"https://www.globenewswire.com/news-release/2026/05/14/3250349/0/en/Oligonucleotides-Clinical-Trial-Drug-Development-Pipeline-Expands-with-Contributions-from-200-Key-Companies-DelveInsight.html","summary":"SGB-9768 was granted Orphan Drug Designation by the FDA for C3 Glomerulopathy."},{"ai_confidence":0.95,"created_at":"2026-05-15T02:16:23.759455","entity":"Brii Biosciences","event_type":"regulatory","id":"7c102b42-f0b3-4adc-a277-29a4820cf86e","impact":"high","pub_date":"2026-05-14","source_url":"https://www.globenewswire.com/news-release/2026/05/14/3250349/0/en/Oligonucleotides-Clinical-Trial-Drug-Development-Pipeline-Expands-with-Contributions-from-200-Key-Companies-DelveInsight.html","summary":"BW-20507 received Breakthrough Therapy Designation in China for chronic hepatitis B treatment."},{"ai_confidence":0.9,"created_at":"2026-05-15T02:16:23.759448","entity":"Wave Life Sciences","event_type":"regulatory","id":"e0bdba8e-2ee3-425f-a6cb-cd9f6e8124ca","impact":"medium","pub_date":"2026-05-14","source_url":"https://www.globenewswire.com/news-release/2026/05/14/3250349/0/en/Oligonucleotides-Clinical-Trial-Drug-Development-Pipeline-Expands-with-Contributions-from-200-Key-Companies-DelveInsight.html","summary":"Wave intends to file an NDA in 2026 for accelerated approval of WVE-N531 based on FDA feedback."},{"ai_confidence":0.9,"created_at":"2026-05-15T02:16:23.759440","entity":"Eisai","event_type":"regulatory","id":"351560c4-f1ca-49a9-9067-5e3dc51cf40f","impact":"medium","pub_date":"2026-05-04","source_url":"https://www.neurologylive.com/view/fda-action-update-week-of-may-4-2026-approvals-extended-review-and-plans-for-nda-filing","summary":"The PDUFA date for lecanemab's subcutaneous autoinjector was extended to August 24, 2026."},{"ai_confidence":0.9,"created_at":"2026-05-15T02:16:23.759433","entity":"Clene Nanoscience","event_type":"regulatory","id":"149e0130-b617-4886-a47b-832d478978eb","impact":"medium","pub_date":"2026-05-04","source_url":"https://www.neurologylive.com/view/fda-action-update-week-of-may-4-2026-approvals-extended-review-and-plans-for-nda-filing","summary":"Clene Nanoscience is preparing to submit an NDA for CNM-Au8 in ALS under the accelerated approval pathway."},{"ai_confidence":0.95,"created_at":"2026-05-15T02:16:23.759425","entity":"Genentech","event_type":"regulatory","id":"c9aa3707-3f38-43fe-b640-60e4b4f9a4c8","impact":"high","pub_date":"2026-05-04","source_url":"https://www.neurologylive.com/view/fda-action-update-week-of-may-4-2026-approvals-extended-review-and-plans-for-nda-filing","summary":"Ocrelizumab gained FDA approval for pediatric relapsing-remitting multiple sclerosis (RRMS)."},{"ai_confidence":0.95,"created_at":"2026-05-15T02:16:23.759411","entity":"Argenx","event_type":"regulatory","id":"56e9bfa2-e869-4bbc-b5d8-8b9ebc902a86","impact":"high","pub_date":"2026-05-04","source_url":"https://www.neurologylive.com/view/fda-action-update-week-of-may-4-2026-approvals-extended-review-and-plans-for-nda-filing","summary":"Efgartigimod received FDA approval for the treatment of seronegative myasthenia gravis."},{"ai_confidence":0.9,"created_at":"2026-05-14T02:01:45.069770","entity":"Oculis","event_type":"regulatory","id":"f7fa4b55-8afc-48d4-8290-ee4f9a2e8cd2","impact":"medium","pub_date":"2026-05-07","source_url":"https://www.scottcoop.com/markets/stocks.php?article=gnwcq-2026-5-7-oculis-announces-agreement-with-fda-on-a-special-protocol-assessment-spa-for-optic-neuritis-registrational-trial","summary":"Oculis' Privosegtor received Orphan Drug status from both the FDA and EMA for Optic Neuritis."},{"ai_confidence":0.9,"created_at":"2026-05-14T02:01:45.069762","entity":"Oculis","event_type":"regulatory","id":"498a6932-cbb7-4183-a984-369f7d5dd1dd","impact":"high","pub_date":"2026-05-07","source_url":"https://www.scottcoop.com/markets/stocks.php?article=gnwcq-2026-5-7-oculis-announces-agreement-with-fda-on-a-special-protocol-assessment-spa-for-optic-neuritis-registrational-trial","summary":"Oculis' Privosegtor received Breakthrough Therapy designation from the FDA for Optic Neuritis."},{"ai_confidence":0.9,"created_at":"2026-05-14T02:01:45.069754","entity":"Oculis","event_type":"regulatory","id":"7a194bed-e943-4258-a9bc-ed7c9bdcc38e","impact":"medium","pub_date":"2026-05-07","source_url":"https://www.scottcoop.com/markets/stocks.php?article=gnwcq-2026-5-7-oculis-announces-agreement-with-fda-on-a-special-protocol-assessment-spa-for-optic-neuritis-registrational-trial","summary":"Oculis announced an agreement with the FDA on a Special Protocol Assessment (SPA) for its Optic Neuritis registrational trial."},{"ai_confidence":0.9,"created_at":"2026-05-14T02:01:45.069746","entity":"Praxis Precision Medicines","event_type":"regulatory","id":"da2e589d-e4f2-401d-82c2-850c493811ad","impact":"medium","pub_date":"2026-05-07","source_url":"https://www.barchart.com/story/news/1770941/praxis-precision-medicines-provides-corporate-update-and-reports-first-quarter-2026-financial-results","summary":"The FDA set a PDUFA target action date of January 29, 2027, for Praxis' ulixacaltamide NDA."},{"ai_confidence":0.9,"created_at":"2026-05-14T02:01:45.069738","entity":"Praxis Precision Medicines","event_type":"regulatory","id":"2694c39b-9cd9-4df2-ae15-f0ff13b0d260","impact":"high","pub_date":"2026-05-07","source_url":"https://www.barchart.com/story/news/1770941/praxis-precision-medicines-provides-corporate-update-and-reports-first-quarter-2026-financial-results","summary":"Praxis' ulixacaltamide was granted Breakthrough Therapy Designation by the FDA in December 2025."},{"ai_confidence":0.9,"created_at":"2026-05-14T02:01:45.069731","entity":"Praxis Precision Medicines","event_type":"regulatory","id":"dcdc08a8-67db-4f76-bf12-bd90a5f0a146","impact":"high","pub_date":"2026-05-07","source_url":"https://www.barchart.com/story/news/1770941/praxis-precision-medicines-provides-corporate-update-and-reports-first-quarter-2026-financial-results","summary":"Praxis Precision Medicines announced FDA acceptance of its NDA for relutrigine."},{"ai_confidence":0.9,"created_at":"2026-05-14T02:01:45.069723","entity":"Praxis Precision Medicines","event_type":"regulatory","id":"41bb9c22-cb56-45e5-99b4-ccf3f1e0b2a9","impact":"high","pub_date":"2026-05-07","source_url":"https://www.barchart.com/story/news/1770941/praxis-precision-medicines-provides-corporate-update-and-reports-first-quarter-2026-financial-results","summary":"Praxis Precision Medicines announced FDA acceptance of its NDA for ulixacaltamide for the treatment of ET."},{"ai_confidence":0.8,"created_at":"2026-05-14T02:01:45.069715","entity":"Savara","event_type":"product","id":"dc2f5e25-b16a-49c4-ace0-3b984cbc182b","impact":"medium","pub_date":"2025-12-31","source_url":"https://www.merlintrader.com/three-2026-fda-decisions/","summary":"Savara's molgramostim could become a reference product in autoimmune PAP if approved, addressing an unmet medical need."},{"ai_confidence":0.9,"created_at":"2026-05-14T02:01:45.069705","entity":"Protagonist Therapeutics","event_type":"regulatory","id":"975f8dec-a2e4-4fe7-90c2-0881c5f7387b","impact":"high","pub_date":"2025-12-31","source_url":"https://www.merlintrader.com/three-2026-fda-decisions/","summary":"Protagonist and Takeda announced FDA accepted rusfertide NDA and granted Priority Review, with a PDUFA goal date in Q3 2026."},{"ai_confidence":0.9,"created_at":"2026-05-14T02:01:45.069670","entity":"Unicycive Therapeutics","event_type":"regulatory","id":"8d547e0a-848c-439e-9e63-26d5c6a36f6f","impact":"medium","pub_date":"2025-12-31","source_url":"https://www.merlintrader.com/three-2026-fda-decisions/","summary":"Unicycive Therapeutics' OLC NDA resubmission has a PDUFA target action date of June 29, 2026."},{"ai_confidence":0.85,"created_at":"2026-05-13T01:46:54.792912","entity":"FDA","event_type":"regulatory","id":"7a1a0289-e8ea-4199-97cb-96c3b327a227","impact":"low","pub_date":"2026-05-06","source_url":"https://www.fda.gov/news-events/fda-newsroom/press-announcements","summary":"The FDA launched one-day inspectional assessments on May 6, 2026, as part of its operational updates."},{"ai_confidence":0.85,"created_at":"2026-05-13T01:46:54.791948","entity":"FDA","event_type":"announcement","id":"a99e8216-2a05-468a-896f-54c71e11498d","impact":"low","pub_date":"2026-05-06","source_url":"https://www.fda.gov/news-events/fda-newsroom/press-announcements","summary":"The FDA expanded its AI capabilities and completed data platform consolidation on May 6, 2026."},{"ai_confidence":0.9,"created_at":"2026-05-13T01:46:54.791940","entity":"FDA","event_type":"regulatory","id":"3799d201-dd59-4e39-bbd2-97f3600fd187","impact":"medium","pub_date":"2026-05-05","source_url":"https://www.fda.gov/news-events/fda-newsroom/press-announcements","summary":"The FDA expanded market access and authorized new ENDS (Electronic Nicotine Delivery Systems) products on May 5, 2026."},{"ai_confidence":0.9,"created_at":"2026-05-13T01:46:54.791932","entity":"FDA","event_type":"regulatory","id":"f7d3a3cc-9e0d-4bf6-8780-b8dc746b641f","impact":"medium","pub_date":"2026-05-01","source_url":"https://www.fda.gov/news-events/fda-newsroom/press-announcements","summary":"The FDA permitted expanded access for an investigational pancreatic cancer drug on May 1, 2026."},{"ai_confidence":0.95,"created_at":"2026-05-13T01:46:54.791923","entity":"Achieve Life Sciences","event_type":"regulatory","id":"7f394e69-8352-48cf-880d-3e340e03b01e","impact":"high","pub_date":"2026-06-15","source_url":"https://www.tipranks.com/news/company-announcements/achieve-life-sciences-charts-delayed-path-to-launch","summary":"Achieve Life Sciences expects a Complete Response Letter for its smoking-cessation program and plans to refile its NDA in late 2026."},{"ai_confidence":0.95,"created_at":"2026-05-13T01:46:54.791911","entity":"Gyre Therapeutics","event_type":"regulatory","id":"2338b59c-a4d9-4657-bf8e-d29fec58165e","impact":"high","pub_date":"2026-05-15","source_url":"https://www.stocktitan.net/news/GYRE/gyre-therapeutics-announces-nmpa-acceptance-of-new-drug-application-bcin7uq8h2m3.html","summary":"Gyre Therapeutics announced China's NMPA accepted its New Drug Application for F351 (hydronidone) for CHB-induced liver fibrosis."},{"ai_confidence":0.95,"created_at":"2026-05-13T01:46:54.791867","entity":"Clene Nanoscience","event_type":"regulatory","id":"822a4394-f0aa-49e0-8e0a-2b217e6b5014","impact":"medium","pub_date":"2026-05-04","source_url":"https://www.neurologylive.com/view/fda-action-update-week-may-4-2026-approvals-extended-review-plans-nda-filing","summary":"Clene Nanoscience is preparing to submit an NDA for CNM-Au8 for ALS under the FDA's accelerated approval pathway in Q3 2026."},{"ai_confidence":0.8,"created_at":"2026-05-12T01:32:06.186434","entity":"Regeneron, Otarmeni","event_type":"regulatory","id":"5192f46f-c148-45ee-9ff9-b7e953b88502","impact":"high","pub_date":"2026-04-20","source_url":"https://www.precisionmedicineonline.com/regulatory-news","summary":"FDA approved Regeneron's Otarmeni, the first gene therapy for OTOF-related genetic hearing loss."},{"ai_confidence":0.8,"created_at":"2026-05-12T01:32:06.186427","entity":"Arrowhead","event_type":"regulatory","id":"f545e261-9a8c-43fd-8934-857a34246236","impact":"high","pub_date":"2026-04-20","source_url":"https://www.precisionmedicineonline.com/regulatory-news","summary":"EMA's CHMP recommended Arrowhead's FCS siRNA for marketing authorization."},{"ai_confidence":0.8,"created_at":"2026-05-12T01:32:06.186419","entity":"Novartis","event_type":"regulatory","id":"94551a9c-5a42-4209-b867-5ce110688cd3","impact":"high","pub_date":"2026-04-20","source_url":"https://www.precisionmedicineonline.com/regulatory-news","summary":"EMA's CHMP recommended Novartis' SMA gene therapy for marketing authorization."},{"ai_confidence":0.8,"created_at":"2026-05-12T01:32:06.186411","entity":"Novartis, Pluvicto","event_type":"regulatory","id":"c1671aa6-0444-4b7e-ad4f-c4ec9be9df55","impact":"high","pub_date":"2026-04-20","source_url":"https://www.precisionmedicineonline.com/regulatory-news","summary":"Novartis withdrew its EMA application for Pluvicto in earlier-line prostate cancer due to concerns about the control arm."},{"ai_confidence":0.8,"created_at":"2026-05-12T01:32:06.186404","entity":"CGBIO","event_type":"regulatory","id":"6dde8fb4-e3ba-4cdc-b30f-fb5a4cd7953a","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.prnewswire.com/news-releases/health-latest-news/fda-approval-list/","summary":"CGBIO received FDA 510(k) Clearance for Patient-Specific Ti."},{"ai_confidence":0.7,"created_at":"2026-05-12T01:32:06.186396","entity":"FDA","event_type":"announcement","id":"f2509459-3f2a-478a-9d91-b4ee6b44bab1","impact":"medium","pub_date":"2025-01-01","source_url":"https://www.biospace.com/fda/published-fda-rejections-point-to-manufacturing-data-gaps-as-key-stumbling-blocks","summary":"FDA decided last year to make complete response letters public, offering insight into therapy rejections."},{"ai_confidence":0.8,"created_at":"2026-05-12T01:32:06.186388","entity":"Replimune, RP1","event_type":"regulatory","id":"ea7b64e9-045a-4e57-a781-d39d86090d01","impact":"high","pub_date":"2026-05-01","source_url":"https://www.biospace.com/fda/published-fda-rejections-point-to-manufacturing-data-gaps-as-key-stumbling-blocks","summary":"FDA issued a Complete Response Letter for Replimune's RP1, citing insufficient data package and single-arm trial concerns."},{"ai_confidence":0.7,"created_at":"2026-05-12T01:32:06.186381","entity":"IBI363","event_type":"regulatory","id":"04efcb7d-05a3-47a1-87dd-49e6412aa83b","impact":"medium","pub_date":"2026-05-10","source_url":"https://www.morningstar.com/news/pr-newswire/20260510cn55678/innovent-announces-ibi363-pd-1il-2-bias-bispecific-fusion-protein-received-third-nmpa-breakthrough-therapy-designation-for-msspmmr-metastatic-colorectal-cancer","summary":"Innovent's IBI363 previously received two FDA Fast Track Designations for non-small cell lung cancer and melanoma."},{"ai_confidence":0.9,"created_at":"2026-05-12T01:32:06.186371","entity":"Innovent, IBI363","event_type":"regulatory","id":"fbecfc65-ccee-4d55-befe-4e251860f72f","impact":"high","pub_date":"2026-05-10","source_url":"https://www.morningstar.com/news/pr-newswire/20260510cn55678/innovent-announces-ibi363-pd-1il-2-bias-bispecific-fusion-protein-received-third-nmpa-breakthrough-therapy-designation-for-msspmmr-metastatic-colorectal-cancer","summary":"Innovent's IBI363 received its third NMPA Breakthrough Therapy Designation for metastatic colorectal cancer."},{"ai_confidence":0.9,"created_at":"2026-05-12T01:32:06.186363","entity":"Clene Nanoscience, CNM-Au8","event_type":"regulatory","id":"a0460c1a-e68b-49a9-8288-a8a492308e63","impact":"medium","pub_date":"2026-05-01","source_url":"https://www.neurologylive.com/view/seizures-signal-occult-cancer-risk-clene-moves-toward-nda-filing-cnm-au8-future-friedreich-ataxia-care","summary":"Clene Nanoscience is preparing to submit an NDA for CNM-Au8 for ALS under FDA's accelerated approval pathway."},{"ai_confidence":0.8,"created_at":"2026-05-12T01:32:06.186355","entity":"Jakafi XR","event_type":"regulatory","id":"e926d25d-7790-42d2-8759-7c9370933c53","impact":"high","pub_date":"2026-05-08","source_url":"https://cancerletter.com/regulatory-news/20260508_1/","summary":"FDA approved Jakafi XR tablets for myelofibrosis, polycythemia vera, and graft-versus-host disease."},{"ai_confidence":0.9,"created_at":"2026-05-12T01:32:06.186346","entity":"AstraZeneca, camizestrant","event_type":"regulatory","id":"4f6d4986-076a-4a28-b628-5319d5c11f2b","impact":"high","pub_date":"2026-05-08","source_url":"https://cancerletter.com/regulatory-news/20260508_1/","summary":"AstraZeneca's breast cancer drug camizestrant received a negative recommendation from the FDA's ODAC."},{"ai_confidence":0.9,"created_at":"2026-05-12T01:32:06.186330","entity":"daraxonrasib","event_type":"regulatory","id":"d6455a9f-2d8f-408e-92a3-82e517386a35","impact":"medium","pub_date":"2026-05-01","source_url":"https://www.mskcc.org/news/new-hope-for-pancreatic-cancer-with-targeted-kras-drug","summary":"FDA authorized expanded access for investigational drug daraxonrasib for pancreatic cancer patients."},{"ai_confidence":0.9,"created_at":"2026-05-12T01:32:06.185276","entity":"daraxonrasib","event_type":"regulatory","id":"4b88e7ed-c1f0-499e-8fbd-98fde3615c29","impact":"high","pub_date":"2025-06-01","source_url":"https://www.mskcc.org/news/new-hope-for-pancreatic-cancer-with-targeted-kras-drug","summary":"FDA granted Breakthrough Therapy designation to investigational drug daraxonrasib for pancreatic cancer."},{"ai_confidence":0.98,"created_at":"2026-05-11T01:16:37.265584","entity":"Egetis Therapeutics","event_type":"regulatory","id":"d125c4c5-b1fa-49f7-952c-df2102fa43bf","impact":"high","pub_date":"2024-01-18","source_url":"https://www.biospace.com/press-releases/egetis-therapeutics-to-participate-in-leading-international-medical-conferences-in-2026","summary":"Egetis Therapeutics' NDA for Emcitate\u00ae (tiratricol) for MCT8 deficiency was accepted by the FDA, granted Priority Review, with a PDUFA date of September 28, 2026."},{"ai_confidence":0.95,"created_at":"2026-05-11T01:16:37.265571","entity":"Axsome Therapeutics","event_type":"regulatory","id":"5274e174-4dcc-4bd6-abfa-8e4097a3fbf4","impact":"medium","pub_date":"2024-05-14","source_url":"https://www.kavout.com/market-lens/what-s-driving-axsome-therapeutics-recent-bull-run","summary":"Axsome Therapeutics received positive FDA feedback confirming its AXS-12 data package is sufficient to support an upcoming NDA filing for narcolepsy."},{"ai_confidence":0.95,"created_at":"2026-05-11T01:16:37.265524","entity":"Axsome Therapeutics","event_type":"regulatory","id":"ed0d1486-f6e8-465e-aafd-7c424ff3fd08","impact":"high","pub_date":"2024-05-14","source_url":"https://www.kavout.com/market-lens/what-s-driving-axsome-therapeutics-recent-bull-run","summary":"Axsome Therapeutics received FDA Priority Review for its sNDA for AXS-05 in Alzheimer's disease agitation, with a PDUFA date of April 30, 2026."},{"ai_confidence":0.9,"created_at":"2026-05-10T01:00:31.232673","entity":"Diakonos Oncology","event_type":"regulatory","id":"7edfc207-62b7-49bd-bfff-99e538e40277","impact":"medium","pub_date":"2024-05-07","source_url":"https://www.prnewswire.com/news-releases/diakonos-oncology-awarded-fast-track-designation-by-fda-for-doc1021-dubodencel-in-unresectable-or-metastatic-cutaneous-melanoma-302137012.html","summary":"Diakonos Oncology received FDA Fast Track designation for DOC1021 (dubodencel) for unresectable or metastatic cutaneous melanoma."},{"ai_confidence":0.9,"created_at":"2026-05-10T01:00:31.232666","entity":"AstraZeneca","event_type":"regulatory","id":"1f70689b-ec27-41d8-a622-77fd9f42432a","impact":"medium","pub_date":"2024-05-07","source_url":"https://www.precisionmedicineonline.com/regulatory-news-fda-approvals","summary":"AstraZeneca's Truqap received FDA Advisory Committee backing for PTEN-Deficient Advanced Prostate Cancer."},{"ai_confidence":0.9,"created_at":"2026-05-10T01:00:31.232656","entity":"Pfizer and Arvinas","event_type":"regulatory","id":"671760e7-7d9a-4b04-9a4e-b3a0aecdb412","impact":"high","pub_date":"2024-05-07","source_url":"https://www.precisionmedicineonline.com/regulatory-news-fda-approvals","summary":"Pfizer and Arvinas' Veppanu received FDA approval for ESR1-Mutated Breast Cancer, alongside Guardant Health CDx."},{"ai_confidence":0.85,"created_at":"2026-05-10T01:00:31.232630","entity":"Revolution Medicines","event_type":"regulatory","id":"6b9346df-6a6c-4ece-aee5-4f6beb412745","impact":"medium","pub_date":"2024-05-07","source_url":"https://www.onclive.com/view/fda-green-lights-expanded-access-protocol-for-daraxonrasib-in-pretreated-metastatic-pdac","summary":"The FDA granted a 'safe to proceed' decision for an expanded access protocol of daraxonrasib for metastatic pancreatic cancer."},{"ai_confidence":0.9,"created_at":"2026-05-10T01:00:31.232610","entity":"Pierre Fabre Pharmaceuticals","event_type":"regulatory","id":"b8e3328a-7143-4dbe-8d1c-c7cecd98a3cc","impact":"medium","pub_date":"2024-05-07","source_url":"https://www.prnewswire.com/news-releases/pierre-fabre-pharmaceuticals-announces-regulatory-update-following-type-a-meeting-with-us-food-and-drug-administration-fda-on-tabelecleucel-biologic-license-application-bla-302138246.html","summary":"Pierre Fabre Pharmaceuticals aligned with the FDA on a path forward for resubmission of the BLA for tabelecleucel."},{"ai_confidence":0.9,"created_at":"2026-05-10T01:00:31.232206","entity":"Bright Uro","event_type":"regulatory","id":"a2bd27b4-ee8f-4c1b-b53b-9cfaec0d695f","impact":"medium","pub_date":"2024-05-07","source_url":"https://www.prnewswire.com/news-releases/bright-uro-receives-fda-clearance-for-glean-abdominal-sensor-302138591.html","summary":"Bright Uro received FDA clearance for its Glean\u00ae Abdominal Sensor, aiming to improve care for lower urinary tract dysfunction."},{"ai_confidence":0.9,"created_at":"2026-05-09T00:01:29.318232","entity":"Ensitrelvir","event_type":"regulatory","id":"856752ed-a03a-4044-a7c7-732e8297d5b8","impact":"medium","pub_date":"2026-01-01","source_url":"https://www.goodrx.com/drugs/news/upcoming-fda-approvals","summary":"Ensitrelvir is anticipated to potentially receive FDA approval for COVID-19 prevention in 2026."},{"ai_confidence":0.9,"created_at":"2026-05-09T00:01:29.318225","entity":"Anaphylm","event_type":"regulatory","id":"b677bfa6-c976-4e5f-806f-805b728147c3","impact":"medium","pub_date":"2026-01-01","source_url":"https://www.goodrx.com/drugs/news/upcoming-fda-approvals","summary":"Anaphylm is anticipated to potentially receive FDA approval for severe allergic reactions in 2026."},{"ai_confidence":0.9,"created_at":"2026-05-09T00:01:29.318218","entity":"Ozempic","event_type":"regulatory","id":"d1b058e9-4ed8-492b-9317-200525cd5941","impact":"medium","pub_date":"2026-01-01","source_url":"https://www.goodrx.com/drugs/news/upcoming-fda-approvals","summary":"Ozempic is anticipated to potentially receive FDA approval for peripheral artery disease in 2026."},{"ai_confidence":1.0,"created_at":"2026-05-09T00:01:29.318211","entity":"Altimmune","event_type":"regulatory","id":"7a44348b-9909-41dc-bc7f-c5439cee297e","impact":"high","pub_date":"2026-01-01","source_url":"https://www.levelfields.ai/news/top-breakthrough-therapy-designations-of-2026","summary":"Altimmune received FDA Breakthrough Therapy Designation for pemvidutide for MASH in 2026."},{"ai_confidence":1.0,"created_at":"2026-05-09T00:01:29.318203","entity":"Neurogene","event_type":"regulatory","id":"5471f577-8860-484d-87e7-e391c049b9da","impact":"high","pub_date":"2026-01-01","source_url":"https://www.levelfields.ai/news/top-breakthrough-therapy-designations-of-2026","summary":"Neurogene received FDA Breakthrough Therapy Designation for NGN-401 for Rett syndrome in 2026."},{"ai_confidence":1.0,"created_at":"2026-05-09T00:01:29.318178","entity":"Larimar Therapeutics","event_type":"regulatory","id":"3a8985c5-fd76-4981-a308-013353f3b918","impact":"high","pub_date":"2026-01-01","source_url":"https://www.levelfields.ai/news/top-breakthrough-therapy-designations-of-2026","summary":"Larimar Therapeutics received FDA Breakthrough Therapy Designation for nomlabofusp for Friedreich's ataxia in 2026."},{"ai_confidence":0.9,"created_at":"2026-05-07T23:47:19.900825","entity":"Developer of n-butyl cyanoacrylate","event_type":"regulatory","id":"e9f4bac8-6bc7-4126-9e1e-c5ae29f31504","impact":"medium","pub_date":"2025-12-31","source_url":"https://www.neurologylive.com/view/fda-action-update-december-2025-acceptance-approval-and-clearance","summary":"FDA expanded n-butyl cyanoacrylate's indication for chronic subdural hematoma, supported by the MEMBRANE trial."},{"ai_confidence":0.95,"created_at":"2026-05-07T23:47:19.900817","entity":"Developer of Tolebrutinib","event_type":"product","id":"e0dbfa4f-bb3b-4677-b541-6a815d82022d","impact":"high","pub_date":"2025-12-31","source_url":"https://www.neurologylive.com/view/fda-action-update-december-2025-acceptance-approval-and-clearance","summary":"Tolebrutinib failed to meet endpoints in a phase 3 study for primary progressive multiple sclerosis, delaying regulatory submission."},{"ai_confidence":0.95,"created_at":"2026-05-07T23:47:19.900809","entity":"Developer of Inebilizumab","event_type":"regulatory","id":"3c35686d-5e1d-4e3e-bc96-bde874e6e2c8","impact":"high","pub_date":"2025-12-31","source_url":"https://www.neurologylive.com/view/fda-action-update-december-2025-acceptance-approval-and-clearance","summary":"Inebilizumab received FDA approval for generalized myasthenia gravis, demonstrating significant efficacy in the MINT trial."},{"ai_confidence":0.9,"created_at":"2026-05-07T23:47:19.900800","entity":"Developer of pridopidine","event_type":"regulatory","id":"baebaea9-e060-4ab3-9e04-9eed878cf8ed","impact":"medium","pub_date":"2025-12-31","source_url":"https://www.neurologylive.com/view/fda-action-update-december-2025-acceptance-approval-and-clearance","summary":"FDA cleared a phase 3 trial for pridopidine in ALS, focusing on efficacy and safety."},{"ai_confidence":0.95,"created_at":"2026-05-07T23:47:19.900792","entity":"Developer of TRN-257","event_type":"regulatory","id":"9ecf9e08-7067-4477-8e52-945d7d2d8a33","impact":"high","pub_date":"2025-12-31","source_url":"https://www.neurologylive.com/view/fda-action-update-december-2025-acceptance-approval-and-clearance","summary":"FDA accepted the NDA for TRN-257 for narcolepsy and idiopathic hypersomnia."},{"ai_confidence":0.9,"created_at":"2026-05-07T23:47:19.900783","entity":"Developer of Irpagratinib","event_type":"regulatory","id":"7ea136f8-5a7c-4a87-87fb-2e10cca459ec","impact":"medium","pub_date":"2026-02-28","source_url":"https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-april-2026","summary":"Irpagratinib received FDA Fast Track designation for hepatocellular carcinoma with FGF19 overexpression in February 2026."},{"ai_confidence":0.9,"created_at":"2026-05-07T23:47:19.900775","entity":"Developer of CTIM-76","event_type":"regulatory","id":"c660c0e7-ef45-4d08-b480-267ea5919959","impact":"medium","pub_date":"2026-04-30","source_url":"https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-april-2026","summary":"FDA granted Fast Track designation to CTIM-76 for ovarian cancer."},{"ai_confidence":0.9,"created_at":"2026-05-07T23:47:19.900767","entity":"Developer of A2B543","event_type":"regulatory","id":"0fda5754-0103-413a-b269-12b27dd4db40","impact":"medium","pub_date":"2026-04-30","source_url":"https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-april-2026","summary":"FDA granted Fast Track designation to A2B543 for solid tumors."},{"ai_confidence":0.9,"created_at":"2026-05-07T23:47:19.900759","entity":"Developer of PAS-004","event_type":"regulatory","id":"d1c78695-4f09-4591-a04b-a8371123b29d","impact":"medium","pub_date":"2026-04-30","source_url":"https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-april-2026","summary":"FDA granted Fast Track designation to PAS-004 for Neurofibromatosis Type 1-associated plexiform neurofibromas."},{"ai_confidence":0.95,"created_at":"2026-05-07T23:47:19.900751","entity":"Terns Pharmaceuticals","event_type":"regulatory","id":"62b8707e-95ad-4d1c-9a90-6d268befb337","impact":"high","pub_date":"2024-05-15","source_url":"https://rarecancernews.com/news/fda-awards-breakthrough-therapy-status-tern-701-chronic-myeloid-leukemia/","summary":"FDA granted Breakthrough Therapy designation to Terns Pharmaceuticals' TERN-701 for chronic myeloid leukemia."},{"ai_confidence":0.85,"created_at":"2026-05-07T23:47:19.900742","entity":"Developer of Iopofosine I 131","event_type":"product","id":"7aa01c49-bd0b-4991-8b7b-59a47e1ff527","impact":"medium","pub_date":"2024-05-15","source_url":"https://www.onclive.com/view/iopofosine-i-131-follow-up-data-show-strong-efficacy-in-waldenstr-m-macroglobulinemia","summary":"Follow-up data for Iopofosine I 131 showed strong efficacy in Waldenstr\u00f6m Macroglobulinemia, supporting an NDA filing."},{"ai_confidence":0.95,"created_at":"2026-05-07T23:47:19.900734","entity":"Developer of Iopofosine I 131","event_type":"regulatory","id":"0501ebcb-1e3a-40f3-9869-338a053614a2","impact":"high","pub_date":"2025-06-01","source_url":"https://www.onclive.com/view/iopofosine-i-131-follow-up-data-show-strong-efficacy-in-waldenstr-m-macroglobulinemia","summary":"Iopofosine I 131 received FDA Breakthrough Therapy designation for Waldenstr\u00f6m Macroglobulinemia in June 2025."},{"ai_confidence":0.9,"created_at":"2026-05-07T23:47:19.900725","entity":"Palvella Therapeutics","event_type":"regulatory","id":"727362e0-a74d-4c4c-b49d-8febcb0c207a","impact":"medium","pub_date":"2026-04-30","source_url":"https://www.investing.com/news/company-news/palvella-q1-2026-slides-262m-cash-fuels-path-to-2027-launch-93CH-4669506","summary":"Palvella Therapeutics announced its QTORIN Rapamycin is on track for NDA submission in H2 2026, with a pre-NDA meeting in Q2 2026."},{"ai_confidence":0.95,"created_at":"2026-05-07T23:47:19.900714","entity":"Praxis Precision Medicines","event_type":"regulatory","id":"af9e2024-e897-49b7-9ce3-6546709593f2","impact":"high","pub_date":"2026-04-30","source_url":"https://www.stocktitan.net/news/PRAX/praxis-precision-medicines-provides-corporate-update-and-reports-1q6j9mc6n1ue.html","summary":"FDA accepted NDAs for Praxis's ulixacaltamide (Essential Tremor) and relutrigine (SCN2A/SCN8A DEEs)."},{"ai_confidence":0.9,"created_at":"2026-05-07T23:47:19.900690","entity":"Oculis","event_type":"regulatory","id":"00f225c5-a086-421e-9bb9-b4f7632a5cae","impact":"medium","pub_date":"2024-05-15","source_url":"https://www.biospace.com/press-releases/oculis-announces-agreement-with-fda-on-a-special-protocol-assessment-spa-for-optic-neuritis-registrational-trial","summary":"Oculis announced FDA agreement on a Special Protocol Assessment for its PIONEER-1 registrational trial of Privosegtor for optic neuritis."},{"ai_confidence":0.85,"created_at":"2026-05-06T23:32:00.460046","entity":"Upadacitinib","event_type":"regulatory","id":"bc120d40-d800-46b4-8ed5-f767d6c60851","impact":"medium","pub_date":"2026-04-28","source_url":"https://www.hcplive.com/clinical/fda-news","summary":"An sNDA for Upadacitinib was submitted to the FDA for severe alopecia areata."},{"ai_confidence":0.95,"created_at":"2026-05-06T23:32:00.460037","entity":"BGF Triple Therapy","event_type":"regulatory","id":"798cd766-37e7-4ec4-90ba-3971605c48db","impact":"high","pub_date":"2026-04-28","source_url":"https://www.hcplive.com/clinical/fda-news","summary":"The FDA approved BGF Triple Therapy for asthma in patients aged 12 and older."},{"ai_confidence":0.9,"created_at":"2026-05-06T23:32:00.460025","entity":"Enhertu","event_type":"regulatory","id":"4abcc042-6251-42a6-b694-7ef70766f2c8","impact":"high","pub_date":"2026-04-01","source_url":"https://www.onclive.com/view/fda-flashback-breast-cancer-decisions-and-news-from-april-2026","summary":"The FDA is reviewing an sBLA for neoadjuvant fam-trastuzumab deruxtecan-nxki (Enhertu) for high-risk, HER2-positive breast cancer, with a PDUFA date of May 18, 2026."},{"ai_confidence":0.85,"created_at":"2026-05-06T23:32:00.459965","entity":"AidaBREAST test","event_type":"regulatory","id":"e2d8afa0-e71f-4c27-b939-82dccf554e7b","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.onclive.com/view/fda-flashback-breast-cancer-decisions-and-news-from-april-2026","summary":"The FDA granted breakthrough device designation to the AidaBREAST test for prognostic risk assessment in early-stage breast cancer."},{"ai_confidence":0.9,"created_at":"2026-05-06T23:32:00.459064","entity":"Camizestrant","event_type":"regulatory","id":"1c131fc9-d9b8-451a-a024-873618af8312","impact":"high","pub_date":"2026-04-01","source_url":"https://www.onclive.com/view/fda-flashback-breast-cancer-decisions-and-news-from-april-2026","summary":"The FDA's ODAC voted 6-3 against the clinical benefit of switching to camizestrant for ESR1 mutation in breast cancer."},{"ai_confidence":0.9,"created_at":"2026-05-06T23:32:00.459050","entity":"GSK plc","event_type":"regulatory","id":"2e938bc9-5455-4fa3-bc3f-9562fb34e341","impact":"high","pub_date":"2024-05-15","source_url":"https://www.delveinsight.com/blog/pharma-news-for-ucb-pfizer-axsome","summary":"GSK's bepirovirsen, an investigational therapy for Chronic Hepatitis B, was granted Breakthrough Therapy Designation by the FDA."},{"ai_confidence":0.9,"created_at":"2026-05-06T23:32:00.459042","entity":"GSK plc","event_type":"regulatory","id":"b9d5448a-f3eb-4753-b157-a1e14f883a64","impact":"high","pub_date":"2024-05-15","source_url":"https://www.delveinsight.com/blog/pharma-news-for-ucb-pfizer-axsome","summary":"GSK plc announced the FDA accepted its NDA for priority review of bepirovirsen for Chronic Hepatitis B, with a PDUFA date of October 26, 2026."},{"ai_confidence":0.9,"created_at":"2026-05-06T23:32:00.459034","entity":"Egetis Therapeutics","event_type":"regulatory","id":"c72a4ab7-201a-4c94-8cd5-b45936995249","impact":"high","pub_date":"2024-05-15","source_url":"https://www.egetis.com/mfn_news/egetis-announces-grant-of-patent-for-mct8-deficiency-composition-in-the-u-s/","summary":"The FDA accepted Egetis' New Drug Application (NDA) for Emcitate\u00ae for MCT8 deficiency, setting a PDUFA date of September 28, 2026."},{"ai_confidence":0.9,"created_at":"2026-05-06T23:32:00.459025","entity":"Egetis Therapeutics","event_type":"regulatory","id":"90d27768-48cf-47aa-8180-33b1fb550f5f","impact":"high","pub_date":"2024-05-15","source_url":"https://www.egetis.com/mfn_news/egetis-announces-grant-of-patent-for-mct8-deficiency-composition-in-the-u-s/","summary":"Egetis' Emcitate\u00ae (tiratricol) was granted FDA Breakthrough Therapy, Orphan Drug, Fast Track, and Rare Pediatric Disease Designations."},{"ai_confidence":0.9,"created_at":"2026-05-06T23:32:00.459009","entity":"Egetis Therapeutics","event_type":"regulatory","id":"38a6db95-c859-4310-9471-94e0cabfe13e","impact":"medium","pub_date":"2024-05-15","source_url":"https://www.egetis.com/mfn_news/egetis-announces-grant-of-patent-for-mct8-deficiency-composition-in-the-u-s/","summary":"Egetis Therapeutics received a U.S. patent for a novel composition containing tiratricol for treating MCT8 deficiency."},{"ai_confidence":1.0,"created_at":"2026-05-05T23:16:28.046913","entity":"Grace Therapeutics","event_type":"regulatory","id":"b2e0c26c-cc16-49b3-a475-4644b38c3751","impact":"high","pub_date":"2026-04-01","source_url":"https://www.neurologylive.com/view/fda-action-update-april-2026-acceptance-clearance-crl","summary":"FDA issued a Complete Response Letter (CRL) for Grace Therapeutics' GTx-104 for aneurysmal subarachnoid hemorrhage, citing CMC and non-clinical issues."},{"ai_confidence":1.0,"created_at":"2026-05-05T23:16:28.046873","entity":"Ultragenyx","event_type":"regulatory","id":"7ab828b1-0d06-4338-be77-9b5cfc3c18e8","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.neurologylive.com/view/fda-action-update-april-2026-acceptance-clearance-crl","summary":"FDA accepted Ultragenyx's resubmitted Biologics License Application (BLA) for UX111 for MPS IIIA, with a PDUFA date of September 19, 2026."},{"ai_confidence":1.0,"created_at":"2026-05-04T23:00:28.036045","entity":"capivasertib","event_type":"regulatory","id":"77d0f171-bfc7-4834-8607-8b16938ccb9d","impact":"medium","pub_date":"2024-01-26","source_url":"https://www.targetedonc.com/view/the-targeted-pulse-fda-decisions-and-breakthrough-data-shape-oncology-landscape","summary":"FDA's Oncologic Drugs Advisory Committee (ODAC) endorsed capivasertib for hormone-sensitive prostate cancer."},{"ai_confidence":1.0,"created_at":"2026-05-04T23:00:28.036030","entity":"zipalertinib","event_type":"regulatory","id":"34db00fc-bbc0-40f5-b3c3-e9349fd8e011","impact":"medium","pub_date":"2024-01-26","source_url":"https://www.targetedonc.com/view/the-targeted-pulse-fda-decisions-and-breakthrough-data-shape-oncology-landscape","summary":"FDA accepted a New Drug Application (NDA) for zipalertinib for EGFR exon 20 insertion-mutant non-small cell lung cancer."},{"ai_confidence":1.0,"created_at":"2026-05-03T22:46:19.193843","entity":"TERN-701","event_type":"regulatory","id":"5433c0d4-979c-4392-80f9-3da5d6d9b74c","impact":"medium","pub_date":"2023-11-13","source_url":"https://www.hmpgloballearningnetwork.com/site/onc/fda-alerts/fda-grants-breakthrough-therapy-designation-tern-701-ph-positive-chronic","summary":"FDA granted Breakthrough Therapy designation to TERN-701 for previously treated Ph-positive chronic myeloid leukemia."},{"ai_confidence":1.0,"created_at":"2026-05-03T22:46:19.193834","entity":"Auvelity","event_type":"product","id":"b255cc83-930c-4ac6-9411-64e97cd3011f","impact":"high","pub_date":"2023-12-15","source_url":"https://www.fda.gov/news-events/press-announcements/fda-approves-first-non-antipsychotic-drug-treat-agitation-associated-dementia","summary":"FDA approved Auvelity, the first non-antipsychotic drug, for treating agitation associated with Alzheimer's dementia."},{"ai_confidence":1.0,"created_at":"2026-05-03T22:46:19.193819","entity":"FDA","event_type":"regulatory","id":"cfe11a70-b69c-4a58-b5bf-15a06ce31b36","impact":"high","pub_date":"2021-01-14","source_url":"https://www.fda.gov/news-events/press-announcements/fda-accelerates-action-treatments-serious-mental-illness-following-executive-order","summary":"FDA announced expedited regulatory actions, including prioritizing Breakthrough Therapy designated treatments, for serious mental illnesses."},{"ai_confidence":1.0,"created_at":"2026-05-02T22:18:08.626536","entity":"Sanofi","event_type":"regulatory","id":"8908e1ba-ddd5-44ca-839d-612dae0e3c84","impact":"high","pub_date":"2024-12-13","source_url":"https://www.sanofi.com/en/media-room/press-releases/2024/2024-12-13-06-00-00-2996609","summary":"Sanofi's tolebrutinib was granted FDA Breakthrough Therapy Designation for non-relapsing secondary progressive multiple sclerosis."},{"ai_confidence":1.0,"created_at":"2026-05-02T22:18:08.626528","entity":"Genmab A/S","event_type":"regulatory","id":"783b01db-bcf2-4859-9462-33acd2915ed5","impact":"high","pub_date":"2025-08-26","source_url":"https://ir.genmab.com/news-releases/news-release-details/genmab-receives-fda-breakthrough-therapy-designation-rinatabart","summary":"Genmab received FDA Breakthrough Therapy Designation for rinatabart sesutecan (Rina-S) for advanced endometrial cancer."},{"ai_confidence":1.0,"created_at":"2026-05-02T22:18:08.626520","entity":"Dyne Therapeutics","event_type":"regulatory","id":"cea20480-ac98-41aa-aa93-7a3fc0d699e0","impact":"high","pub_date":"2025-08-04","source_url":"https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-announces-fda-breakthrough-therapy-0/","summary":"Dyne Therapeutics received FDA Breakthrough Therapy Designation for DYNE-251 in Duchenne muscular dystrophy."},{"ai_confidence":0.9,"created_at":"2026-05-02T22:18:08.626512","entity":"Axsome Therapeutics","event_type":"regulatory","id":"64d71f95-20ef-4c94-8b69-3e0fe7f54c64","impact":"high","pub_date":"2024-01-01","source_url":"https://investingnews.com/axsome-therapeutics-announces-fda-approval-of-auvelity-r-for-the-treatment-of-agitation-associated-with-dementia-due-to-alzheimer-s-disease/","summary":"Axsome Therapeutics announced FDA approval of AUVELITY for treating agitation associated with dementia due to Alzheimer's disease."},{"ai_confidence":1.0,"created_at":"2026-05-02T22:18:08.626496","entity":"GSK, Ionis Pharmaceuticals","event_type":"regulatory","id":"fff4564e-6250-41cc-a05c-779ee16e79e4","impact":"high","pub_date":"2026-04-27","source_url":"https://www.morningstar.com/news/business-wire/20260427721143/ionis-partner-gsk-announces-bepirovirsen-accepted-for-priority-review-and-granted-breakthrough-therapy-designation-by-us-fda-as-a-potential-first-in-class-medicine-for-chronic-hepatitis-b","summary":"GSK and Ionis's bepirovirsen for chronic hepatitis B received FDA Priority Review and Breakthrough Therapy Designation."},{"ai_confidence":0.85,"created_at":"2026-05-01T22:01:49.198960","entity":"Lurbinectedin & Atezolizumab","event_type":"regulatory","id":"bdbd8f81-9c45-46b4-bdec-54c89d29decb","impact":"high","pub_date":"2025-04-07","source_url":"https://www.empr.com/news/fda-drug-approval-decisions-expected-in-october-2025/","summary":"FDA granted Priority Review to the sNDA for lurbinectedin + atezolizumab for extensive-stage small cell lung cancer."},{"ai_confidence":0.9,"created_at":"2026-05-01T22:01:49.198950","entity":"Axsome Therapeutics","event_type":"regulatory","id":"b9fd6140-c33b-407c-87f8-aec269899f93","impact":"high","pub_date":"2026-04-30","source_url":"https://www.psychiatricimes.com/view/morning-rounds-news-in-psych-from-april-20-26","summary":"FDA's PDUFA target action date for Axsome Therapeutics' sNDA for AXS-05 in Alzheimer disease agitation is April 30, 2026."},{"ai_confidence":0.9,"created_at":"2026-05-01T22:01:49.198934","entity":"Noribogaine hydrochloride","event_type":"regulatory","id":"ec2ef0b5-bc81-4020-aa55-bfb235fa84ae","impact":"medium","pub_date":"2026-04-20","source_url":"https://www.psychiatricimes.com/view/morning-rounds-news-in-psych-from-april-20-26","summary":"FDA cleared the first US clinical study of noribogaine hydrochloride for alcohol use disorder."},{"ai_confidence":0.9,"created_at":"2026-05-01T22:01:49.198875","entity":"Transcend Therapeutics","event_type":"regulatory","id":"3541c640-5b41-4959-9dde-30a122f70462","impact":"medium","pub_date":"2026-04-20","source_url":"https://www.psychiatricimes.com/view/morning-rounds-news-in-psych-from-april-20-26","summary":"FDA issued a National Priority Voucher to Transcend Therapeutics for methylone for posttraumatic stress disorder."},{"ai_confidence":0.9,"created_at":"2026-05-01T22:01:49.197906","entity":"Usona Institute","event_type":"regulatory","id":"8c918caf-be6a-4222-94cf-21b65d56e0f2","impact":"medium","pub_date":"2026-04-20","source_url":"https://www.psychiatricimes.com/view/morning-rounds-news-in-psych-from-april-20-26","summary":"FDA issued a National Priority Voucher to Usona Institute for psilocybin for major depressive disorder."},{"ai_confidence":0.9,"created_at":"2026-05-01T22:01:49.197853","entity":"AstraZeneca","event_type":"regulatory","id":"22941962-e0c8-47c3-ae90-f0eac18faa05","impact":"medium","pub_date":"2026-04-30","source_url":"https://www.astrazeneca-us.com/media/press-releases/2026/Update-on-FDA-Advisory-Committee-vote-on-camizestrant-in-combination-with-a-CDK-4-6-inhibitor-for-advanced-HR-positive-breast-cancer.html","summary":"AstraZeneca's camizestrant combination received FDA Breakthrough Therapy Designation in May 2025."},{"ai_confidence":0.9,"created_at":"2026-05-01T22:01:49.197816","entity":"AstraZeneca","event_type":"regulatory","id":"5eeb1695-3566-497f-a9e6-8aef72eca4f4","impact":"high","pub_date":"2026-04-30","source_url":"https://www.astrazeneca-us.com/media/press-releases/2026/Update-on-FDA-Advisory-Committee-vote-on-camizestrant-in-combination-with-a-CDK-4-6-inhibitor-for-advanced-HR-positive-breast-cancer.html","summary":"FDA's ODAC did not recommend AstraZeneca's camizestrant combination for 1st-line HR-positive, HER2-negative advanced breast cancer."},{"ai_confidence":0.85,"created_at":"2026-05-01T22:01:49.197739","entity":"Zipalertinib","event_type":"regulatory","id":"648fcd87-1de4-45d6-b1ec-55f185e7f9c4","impact":"high","pub_date":"2026-08-27","source_url":"https://www.onclive.com/view/fda-accepts-nda-for-zipalertinib-in-locally-advanced-or-metastatic-egfr-exon-20-nsclc","summary":"FDA accepted the New Drug Application (NDA) for zipalertinib for EGFR exon 20+ NSCLC, with a PDUFA date of Feb 27, 2027."},{"ai_confidence":0.8,"created_at":"2026-05-01T22:01:49.197544","entity":"Ibogaine","event_type":"regulatory","id":"04aaf80c-211d-4781-8839-7b54513e7f66","impact":"medium","pub_date":"2026-04-29","source_url":"https://www.mindscaperetreat.com/news/ibogaine-fda-approval-status-2026","summary":"A formal Breakthrough Therapy designation request for ibogaine in opioid use disorder is pending FDA review."},{"ai_confidence":0.8,"created_at":"2026-05-01T22:01:49.197532","entity":"Ibogaine","event_type":"regulatory","id":"057da4c2-e338-4f15-bc92-25ceaf903b62","impact":"medium","pub_date":"2026-04-29","source_url":"https://www.mindscaperetreat.com/news/ibogaine-fda-approval-status-2026","summary":"Multiple Investigational New Drug (IND) applications for ibogaine are now active, allowing US research."},{"ai_confidence":0.9,"created_at":"2026-05-01T22:01:49.197506","entity":"Compass Pathways","event_type":"regulatory","id":"047e5ea9-b273-4ce6-95d1-305bc18dd561","impact":"medium","pub_date":"2026-04-20","source_url":"https://allsci.com/news/approvals/fda-points-way-forward-for-compass-pathways-psilocybin-in-treatment-resistant-depression/","summary":"FDA selected Compass Pathways' COMP360 for its Commissioner's National Priority Voucher pilot program, shortening review."},{"ai_confidence":0.9,"created_at":"2026-05-01T22:01:49.197411","entity":"Compass Pathways","event_type":"regulatory","id":"da21c8dd-ccec-4606-a634-f2f21296e148","impact":"high","pub_date":"2026-04-20","source_url":"https://allsci.com/news/approvals/fda-points-way-forward-for-compass-pathways-psilocybin-in-treatment-resistant-depression/","summary":"FDA granted Compass Pathways a rolling New Drug Application (NDA) review for COMP360 (psilocybin) for TRD."},{"ai_confidence":1.0,"created_at":"2026-04-30T21:47:23.426788","entity":"FDA","event_type":"regulatory","id":"69924540-1648-48ed-97ec-2074550747ac","impact":"medium","pub_date":"2026-02-23","source_url":"https://www.fda.gov/news-events/press-announcements/fda-launches-framework-accelerating-development-individualized-therapies-ultra-rare-diseases","summary":"FDA issued draft guidance to accelerate development of individualized therapies for ultra-rare diseases."},{"ai_confidence":1.0,"created_at":"2026-04-29T21:31:38.103744","entity":"Daiichi Sankyo and Merck","event_type":"regulatory","id":"faa63536-25c5-4da5-bbe0-9f1c02e5fcd8","impact":"high","pub_date":"2025-08-18","source_url":"https://daiichisankyo.us/press-releases/-/article/ifinatamab-deruxtecan-granted-breakthrough-therapy-designation-by-us-fda-for-patients-with-pretreated-extensive-stage-small-cell-lung-cancer","summary":"The FDA granted Breakthrough Therapy Designation to ifinatamab deruxtecan for pretreated extensive-stage small cell lung cancer."},{"ai_confidence":0.9,"created_at":"2026-04-29T21:31:38.103733","entity":"ProteinQure","event_type":"regulatory","id":"d80be84c-2eb2-4f08-906a-49a449885d5a","impact":"medium","pub_date":"2025-08-07","source_url":"https://www.oncologynewscentral.com/drugs/info/oncology-drugs-granted-fda-designations-in-august-2025","summary":"The FDA granted Fast Track Designation to ProteinQure's PQ203 for triple-negative breast cancer."},{"ai_confidence":1.0,"created_at":"2026-04-29T21:31:38.103694","entity":"Dizal","event_type":"regulatory","id":"e73b42ec-ee44-43f2-846a-0c2d3c96e800","impact":"medium","pub_date":"2025-08-06","source_url":"https://www.oncologynewscentral.com/drugs/info/oncology-drugs-granted-fda-designations-in-august-2025","summary":"The FDA granted Fast Track Designation to Dizal's birelentinib for relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma."},{"ai_confidence":1.0,"created_at":"2026-04-29T21:31:38.103656","entity":"Exelixis, Inc.","event_type":"regulatory","id":"98bfa0cd-0ff5-42bc-95aa-edf832e500fb","impact":"high","pub_date":"2015-08-24","source_url":"https://ir.exelixis.com/news-releases/news-release-details/fda-grants-breakthrough-therapy-designation-exelixis","summary":"The FDA granted Breakthrough Therapy Designation to Exelixis' cabozantinib for advanced renal cell carcinoma in patients who received one prior therapy."},{"ai_confidence":0.8,"created_at":"2026-04-29T21:31:38.103645","entity":"ARS Pharmaceuticals","event_type":"announcement","id":"b0d6878c-2f61-4b8a-8c09-5fce120f6e2f","impact":"medium","pub_date":"2024-01-01","source_url":"https://www.goodrx.com/drugs/news/upcoming-fda-approvals?srsltid=AfmBOooW8coCc04Z3ZTNCDCB2Uf466LfAeIkvceMZz4QeLHe3URyLPu3","summary":"GoodRx announced that Anaphylm (epinephrine film) is among several highly anticipated treatments seeking first-time FDA approval in 2026."},{"ai_confidence":0.8,"created_at":"2026-04-29T21:31:38.103604","entity":"Shionogi","event_type":"announcement","id":"961e64d4-c22f-41ac-a2a4-d7162c1c4f3a","impact":"medium","pub_date":"2024-01-01","source_url":"https://www.goodrx.com/drugs/news/upcoming-fda-approvals?srsltid=AfmBOooW8coCc04Z3ZTNCDCB2Uf466LfAeIkvceMZz4QeLHe3URyLPu3","summary":"GoodRx announced that ensitrelvir is among several highly anticipated treatments seeking first-time FDA approval in 2026."},{"ai_confidence":0.8,"created_at":"2026-04-29T21:31:38.103564","entity":"AstraZeneca","event_type":"announcement","id":"942a89b2-b2c0-4a56-b754-55d7690184f6","impact":"medium","pub_date":"2024-01-01","source_url":"https://www.goodrx.com/drugs/news/upcoming-fda-approvals?srsltid=AfmBOooW8coCc04Z3ZTNCDCB2Uf466LfAeIkvceMZz4QeLHe3URyLPu3","summary":"GoodRx announced that Saphnelo (anifrolumab) is among several highly anticipated treatments that may receive FDA approval for new uses in 2026."},{"ai_confidence":0.8,"created_at":"2026-04-29T21:31:38.103521","entity":"MannKind Corporation","event_type":"announcement","id":"6226274e-e68e-4d09-9bf6-1e6eb8b4b3ef","impact":"medium","pub_date":"2024-01-01","source_url":"https://www.goodrx.com/drugs/news/upcoming-fda-approvals?srsltid=AfmBOooW8coCc04Z3ZTNCDCB2Uf466LfAeIkvceMZz4QeLHe3URyLPu3","summary":"GoodRx announced that Afrezza (inhaled insulin) is among several highly anticipated treatments that may receive FDA approval for new uses in 2026."},{"ai_confidence":0.8,"created_at":"2026-04-29T21:31:38.103474","entity":"Novo Nordisk","event_type":"announcement","id":"aa067bac-9a3b-4643-932e-d472594bc23e","impact":"medium","pub_date":"2024-01-01","source_url":"https://www.goodrx.com/drugs/news/upcoming-fda-approvals?srsltid=AfmBOooW8coCc04Z3ZTNCDCB2Uf466LfAeIkvceMZz4QeLHe3URyLPu3","summary":"GoodRx announced that Wegovy (semaglutide) and CagriSema are among several highly anticipated treatments that may receive FDA approval in 2026."},{"ai_confidence":1.0,"created_at":"2026-04-28T21:15:19.811690","entity":"Beren Therapeutics P.B.C","event_type":"regulatory","id":"01faffcc-2daf-4b9e-854f-a30b27bbf2d7","impact":"high","pub_date":"2025-12-10","source_url":"https://finance.yahoo.com/news/fda-grants-breakthrough-therapy-designation-225600248.html","summary":"FDA granted Breakthrough Therapy Designation to Beren Therapeutics' investigational drug Adrabetadex for Infantile-Onset Niemann-Pick Disease Type C."},{"ai_confidence":0.9,"created_at":"2026-04-27T21:01:42.888687","entity":"ponatinib","event_type":"regulatory","id":"ab3c0023-4e13-4066-af75-2ff5a7cf6e1e","impact":"high","pub_date":"2013-10-01","source_url":"https://www.nejm.org/doi/full/10.1056/NEJMhle1311493","summary":"FDA briefly suspended approval for ponatinib, a leukemia medication, in October 2013 due to emerging safety data."},{"ai_confidence":0.9,"created_at":"2026-04-27T21:01:42.888670","entity":"FDA","event_type":"regulatory","id":"52e612b6-8ee9-451c-bcd5-301faf2a65a3","impact":"high","pub_date":"2013-11-21","source_url":"https://www.nejm.org/doi/full/10.1056/NEJMhle1311493","summary":"The FDA introduced a new breakthrough-drug category to expedite the development and review of promising therapies."},{"ai_confidence":0.95,"created_at":"2026-04-26T20:47:05.183001","entity":"Abbvie","event_type":"regulatory","id":"5fce209f-06cb-4549-8c16-141e5bc4a20c","impact":"high","pub_date":"2026-04-01","source_url":"https://www.primetherapeutics.com/news/fda-decisions-expected-april-2026/","summary":"Abbvie submitted an NDA for PVEK, a CD123-targeting ADC for BPDCN, which received Breakthrough Therapy designation."},{"ai_confidence":0.9,"created_at":"2026-04-26T20:47:05.182994","entity":"Epizyme","event_type":"regulatory","id":"6db4b000-9c6f-42a4-8989-1f7887089545","impact":"medium","pub_date":"2024-06-18","source_url":"https://fomatmedical.com/blogs-updates/fda-pdufa-dates/","summary":"Epizyme's Tazverik for follicular lymphoma has a Priority Review target FDA action date of June 18."},{"ai_confidence":0.9,"created_at":"2026-04-26T20:47:05.182987","entity":"Viela Bio","event_type":"regulatory","id":"deaa3328-2db8-46a1-a588-23a1049579a7","impact":"medium","pub_date":"2024-06-11","source_url":"https://fomatmedical.com/blogs-updates/fda-pdufa-dates/","summary":"Viela Bio's inebilizumab for NMOSD has a target FDA action date of June 11, holding Breakthrough Therapy designation."},{"ai_confidence":0.9,"created_at":"2026-04-26T20:47:05.182979","entity":"Astellas, Pfizer, Merck","event_type":"regulatory","id":"f63aefd5-18cb-44fa-8109-f1aebfea2e97","impact":"medium","pub_date":"2026-08-17","source_url":"https://www.fiercepharma.com/pharma/fierce-pharma-regulatory-tracker-2026","summary":"FDA is reviewing Astellas/Pfizer's Padcev with Merck's Keytruda for bladder cancer, with a decision expected by August 17."},{"ai_confidence":0.9,"created_at":"2026-04-26T20:47:05.182964","entity":"GSK","event_type":"regulatory","id":"59c1b771-3423-4f41-b6ee-f20762c60044","impact":"medium","pub_date":"2026-01-01","source_url":"https://www.fiercepharma.com/pharma/fierce-pharma-regulatory-tracker-2026","summary":"China's NMPA approved GSK's Blenrep for relapsed or refractory multiple myeloma, based on the Dreamm-7 study."},{"ai_confidence":0.8,"created_at":"2026-04-25T20:32:10.343409","entity":"Targeted Oncology","event_type":"announcement","id":"77bf65f9-e09d-4d82-a3a4-88a6e4a86525","impact":"low","pub_date":"2025-11-02","source_url":"https://www.targetedonc.com/view/october-2025-a-look-at-fda-oncology-approvals-and-designations","summary":"Targeted Oncology published an article summarizing FDA oncology approvals and designations that occurred in October 2025."},{"ai_confidence":0.9,"created_at":"2026-04-25T20:32:10.343402","entity":"FDA (CDER)","event_type":"announcement","id":"ed083145-09b7-4988-9cf4-9f7589a49285","impact":"low","pub_date":"2026-01-01","source_url":"https://www.fda.gov/media/190705/download?attachment","summary":"The FDA's CDER released its 15th annual report, 'Advancing Health Through Innovation: New Drug Therapy Approvals 2025'."},{"ai_confidence":0.95,"created_at":"2026-04-25T20:32:10.343395","entity":"Greenwich LifeSciences Inc.","event_type":"regulatory","id":"b658ec43-0de3-4187-8563-f5fde7fbc125","impact":"high","pub_date":"2025-09-10","source_url":"https://www.oncologynewscentral.com/drugs/info/oncology-drugs-granted-fda-designations-in-september-2025","summary":"The FDA granted fast track designation to Greenwich LifeSciences' GLSI-100 for HER2-Positive Breast Cancer."},{"ai_confidence":0.95,"created_at":"2026-04-25T20:32:10.343387","entity":"CERo Therapeutics Holdings Inc.","event_type":"regulatory","id":"0c1e0ec0-8764-4315-b861-29d2d3702325","impact":"high","pub_date":"2025-09-05","source_url":"https://www.oncologynewscentral.com/drugs/info/oncology-drugs-granted-fda-designations-in-september-2025","summary":"The FDA granted fast track designation to CERo Therapeutics' investigational T-cell therapy, CER-1236, for acute myeloid leukemia."},{"ai_confidence":0.8,"created_at":"2026-04-25T20:32:10.343380","entity":"NRx Pharmaceuticals","event_type":"regulatory","id":"c8423b39-429e-43a7-bb84-19d250ec8160","impact":"high","pub_date":"2026-04-19","source_url":"https://www.stocktitan.net/news/NRXP/n-rx-pharmaceuticals-nasdaq-nrxp-welcomes-presidential-initiative-to-xwmoyikxcx09.html","summary":"NRx Pharmaceuticals' NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression."},{"ai_confidence":0.85,"created_at":"2026-04-25T20:32:10.343372","entity":"NRx Pharmaceuticals","event_type":"regulatory","id":"508fe714-6150-4c18-b166-42282cc4890f","impact":"medium","pub_date":"2026-04-19","source_url":"https://www.stocktitan.net/news/NRXP/n-rx-pharmaceuticals-nasdaq-nrxp-welcomes-presidential-initiative-to-xwmoyikxcx09.html","summary":"NRx Pharmaceuticals applied for a Commissioner's National Priority Voucher in support of its upcoming NDA for NRX-100."},{"ai_confidence":0.8,"created_at":"2026-04-25T20:32:10.343364","entity":"NRx Pharmaceuticals","event_type":"announcement","id":"b6b95059-0f7b-465e-a505-9cfa3f6f21db","impact":"low","pub_date":"2026-04-19","source_url":"https://www.stocktitan.net/news/NRXP/n-rx-pharmaceuticals-nasdaq-nrxp-welcomes-presidential-initiative-to-xwmoyikxcx09.html","summary":"NRx Pharmaceuticals welcomed President Trump's Executive Order to accelerate the approval of psychedelic medications."},{"ai_confidence":0.85,"created_at":"2026-04-25T20:32:10.343356","entity":"FDA, DEA","event_type":"regulatory","id":"2344b2d9-1437-4ca2-abb3-f9309050016c","impact":"medium","pub_date":"2026-04-18","source_url":"https://www.orrick.com/en/Insights/2026/04/President-Trumps-Executive-Order-Accelerates-Psychedelic-Therapies","summary":"President Trump's Executive Order instructs the FDA and DEA to facilitate patient access to psychedelic drugs under the Right to Try Act."},{"ai_confidence":0.9,"created_at":"2026-04-25T20:32:10.343348","entity":"FDA","event_type":"regulatory","id":"9436b3be-16cd-4ef2-83f3-4f729e0d4ab8","impact":"high","pub_date":"2026-04-18","source_url":"https://www.orrick.com/en/Insights/2026/04/President-Trumps-Executive-Order-Accelerates-Psychedelic-Therapies","summary":"President Trump's Executive Order directs the FDA to provide Commissioner's National Priority Vouchers for psychedelic drugs."},{"ai_confidence":0.95,"created_at":"2026-04-25T20:32:10.343327","entity":"US Government","event_type":"regulatory","id":"1334343b-0058-4395-97d6-4bdb136d2856","impact":"high","pub_date":"2026-04-18","source_url":"https://psychedelicalpha.com/news/president-trump-signs-executive-order-to-accelerate-psychedelic-research-and-access/","summary":"President Trump signed an Executive Order on April 18, 2026, to accelerate research and access to psychedelic drugs for mental health."},{"ai_confidence":0.9,"created_at":"2026-04-25T20:32:10.343311","entity":"Compass Pathways","event_type":"product","id":"7361fb0b-8684-4c40-9331-eba9799efbd8","impact":"medium","pub_date":"2026-04-24","source_url":"https://www.morningstar.com/news/business-wire/20260424121830/compass-pathways-announces-fda-granted-nda-rolling-review-request-and-awarded-commissioners-national-priority-voucher","summary":"Compass Pathways is preparing to submit its New Drug Application (NDA) for COMP360 in Q4, based on positive Phase 3 clinical trial data."},{"ai_confidence":0.95,"created_at":"2026-04-25T20:32:10.342655","entity":"Compass Pathways","event_type":"regulatory","id":"1da87166-ce98-49f6-b2c9-638dd4e5512d","impact":"high","pub_date":"2026-04-24","source_url":"https://www.morningstar.com/news/business-wire/20260424121830/compass-pathways-announces-fda-granted-nda-rolling-review-request-and-awarded-commissioners-national-priority-voucher","summary":"Compass Pathways received a rolling NDA review from the FDA and was awarded a Commissioner's National Priority Voucher for COMP360."},{"ai_confidence":0.85,"created_at":"2026-04-25T20:32:10.342632","entity":"FDA","event_type":"announcement","id":"e5239d87-71a8-4844-80f8-103b3a348c40","impact":"medium","pub_date":"2026-04-24","source_url":"https://psychedelicalpha.com/news/breaking-fda-awards-priority-review-vouchers-to-otsuka-compass-and-usona/","summary":"The FDA announced it will imminently release its final guidance for sponsors developing psychedelic drugs."},{"ai_confidence":0.9,"created_at":"2026-04-25T20:32:10.342614","entity":"Otsuka/Transcend","event_type":"regulatory","id":"f8007245-736d-4a63-977a-9a554d1ed838","impact":"high","pub_date":"2026-04-24","source_url":"https://psychedelicalpha.com/news/breaking-fda-awards-priority-review-vouchers-to-otsuka-compass-and-usona/","summary":"The FDA awarded a Commissioner's National Priority Voucher to Otsuka/Transcend for their respective psychedelic programs."},{"ai_confidence":0.9,"created_at":"2026-04-25T20:32:10.342563","entity":"Usona Institute","event_type":"regulatory","id":"0c8a9deb-acc5-438f-b0a6-80be38933a64","impact":"high","pub_date":"2026-04-24","source_url":"https://psychedelicalpha.com/news/breaking-fda-awards-priority-review-vouchers-to-otsuka-compass-and-usona/","summary":"The FDA awarded a Commissioner's National Priority Voucher to Usona Institute for its psilocybin program for major depressive disorder."},{"ai_confidence":0.95,"created_at":"2026-04-24T20:15:39.564501","entity":"Daiichi Sankyo and AstraZeneca","event_type":"regulatory","id":"005c669c-f442-4e14-a92f-7b66116f5c1c","impact":"high","pub_date":"2025-08-19","source_url":"https://www.curetoday.com/view/fda-grants-breakthrough-therapy-designation-to-i-dxd-in-sclc","summary":"Daiichi Sankyo and AstraZeneca's Ifinatamab deruxtecan (I-DXd) received FDA Breakthrough Therapy Designation for extensive-stage SCLC."},{"ai_confidence":0.95,"created_at":"2026-04-24T20:15:39.563573","entity":"Roche","event_type":"regulatory","id":"00554f9d-9ff1-425e-8ae4-74d6b9a82f0d","impact":"high","pub_date":"2025-02-01","source_url":"https://www.neurologylive.com/view/fda-action-update-february-2025-approvals-designations-and-acceptances","summary":"Roche's tablet form of risdiplam received FDA approval for spinal muscular atrophy, enhancing treatment convenience."},{"ai_confidence":0.95,"created_at":"2026-04-24T20:15:39.563560","entity":"Alector","event_type":"regulatory","id":"d5ecf1f5-813a-42e7-8eb2-c9f46f45405f","impact":"high","pub_date":"2025-02-01","source_url":"https://www.neurologylive.com/view/fda-action-update-february-2025-approvals-designations-and-acceptances","summary":"Alector's amlenetug received FDA Fast Track Designation for multiple system atrophy."},{"ai_confidence":0.95,"created_at":"2026-04-24T20:15:39.563551","entity":"T3D Therapeutics","event_type":"regulatory","id":"f8b90a4b-4113-4ba7-b267-e2fee3067a44","impact":"high","pub_date":"2025-02-01","source_url":"https://www.neurologylive.com/view/fda-action-update-february-2025-approvals-designations-and-acceptances","summary":"T3D Therapeutics' troculeucel received FDA Fast Track Designation for Alzheimer's disease."},{"ai_confidence":0.95,"created_at":"2026-04-24T20:15:39.563542","entity":"Biohaven Pharmaceuticals","event_type":"regulatory","id":"64c7d368-f3ae-4a41-8fba-442f50dae8c7","impact":"medium","pub_date":"2025-02-01","source_url":"https://www.neurologylive.com/view/fda-action-update-february-2025-approvals-designations-and-acceptances","summary":"Biohaven Pharmaceuticals' NDA for Troriluzole was accepted by the FDA for spinocerebellar ataxia, potentially the first treatment."},{"ai_confidence":0.95,"created_at":"2026-04-24T20:15:39.563533","entity":"SpringWorks Therapeutics","event_type":"regulatory","id":"d458bf0c-9fd9-4dda-bbbc-f906b64a9596","impact":"high","pub_date":"2025-02-01","source_url":"https://www.neurologylive.com/view/fda-action-update-february-2025-approvals-designations-and-acceptances","summary":"SpringWorks Therapeutics' Mirdametinib received FDA approval for NF1-associated plexiform neurofibromas."},{"ai_confidence":0.95,"created_at":"2026-04-24T20:15:39.563522","entity":"Supernus Pharmaceuticals","event_type":"regulatory","id":"6239b3cb-5746-4a8f-a4cb-a6ab90003b2a","impact":"high","pub_date":"2025-02-01","source_url":"https://www.neurologylive.com/view/fda-action-update-february-2025-approvals-designations-and-acceptances","summary":"Supernus Pharmaceuticals' SPN-830, a subcutaneous apomorphine infusion device, received FDA approval for advanced Parkinson's disease."},{"ai_confidence":0.95,"created_at":"2026-04-24T20:15:39.563476","entity":"Ensem Therapeutics Inc.","event_type":"regulatory","id":"3d8983ef-5cd0-4b76-80dc-e1590e687fb2","impact":"high","pub_date":"2025-10-01","source_url":"https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-october-2025","summary":"Ensem Therapeutics Inc. received FDA Fast Track Designation for ETX-636 for PIK3CA-mutant, HR+/HER2\u2212 advanced breast cancer."},{"ai_confidence":1.0,"created_at":"2026-04-23T20:07:53.137374","entity":"IDEAYA Biosciences, Inc.","event_type":"regulatory","id":"07f94772-87f2-4b32-a381-0e8a225edeac","impact":"medium","pub_date":"2025-03-31","source_url":"https://www.prnewswire.com/news-releases/ideaya-biosciences-receives-us-fda-breakthrough-therapy-designation-for-darovasertib-monotherapy-in-neoadjuvant-uveal-melanoma-302415020.html","summary":"IDEAYA Biosciences' darovasertib received FDA Breakthrough Therapy Designation for neoadjuvant uveal melanoma."},{"ai_confidence":1.0,"created_at":"2026-04-23T20:07:53.137365","entity":"Revolution Medicines, Inc.","event_type":"regulatory","id":"289312f5-6064-483b-994b-cf3575c9884d","impact":"medium","pub_date":"2025-07-23","source_url":"https://ir.revmed.com/news-releases/news-release-details/revolution-medicines-announces-fda-breakthrough-therapy-0/","summary":"Revolution Medicines' elironrasib received FDA Breakthrough Therapy Designation for KRAS G12C-mutated non-small cell lung cancer."},{"ai_confidence":1.0,"created_at":"2026-04-23T20:07:53.137357","entity":"FDA","event_type":"announcement","id":"b772419f-db25-4de6-9292-b0f2c4ba8262","impact":"low","pub_date":"2024-06-30","source_url":"https://trial.medpath.com/news/ef432cae8b77ab2f/fda-breakthrough-therapy-designation-shows-38-7-approval-rate-with-317-products-receiving-market-authorization","summary":"As of June 30, 2024, the FDA has granted 587 Breakthrough Therapy Designations, with 317 products successfully receiving approval."},{"ai_confidence":1.0,"created_at":"2026-04-23T20:07:53.137349","entity":"Daiichi Sankyo, Merck","event_type":"regulatory","id":"dadf9a40-b7d5-4aef-b2ef-bba4f055cbb3","impact":"medium","pub_date":"2025-08-18","source_url":"https://www.merck.com/news/ifinatamab-deruxtecan-granted-breakthrough-therapy-designation-by-u-s-fda-for-patients-with-pretreated-extensive-stage-small-cell-lung-cancer/","summary":"Daiichi Sankyo and Merck's Ifinatamab deruxtecan received FDA Breakthrough Therapy Designation for extensive-stage small cell lung cancer."},{"ai_confidence":0.9,"created_at":"2026-04-23T20:07:53.137341","entity":"Encoded Therapeutics","event_type":"regulatory","id":"82097987-2925-46d9-af2f-b12c241ec1ec","impact":"medium","pub_date":"2025-06-30","source_url":"https://www.rarediseaseadvisor.com/news/fda-grants-breakthrough-therapy-designation-etx101-ds/","summary":"Encoded Therapeutics' investigational gene therapy ETX101 received FDA Breakthrough Therapy Designation for Dravet syndrome."},{"ai_confidence":0.9,"created_at":"2026-04-23T20:07:53.137334","entity":"Nature","event_type":"announcement","id":"682d931c-5d8d-4435-b2bc-99f40f77cc8c","impact":"low","pub_date":"2026-01-01","source_url":"https://www.nature.com/articles/d41573-026-00001-z","summary":"Nature.com published an article summarizing the FDA's drug approvals for the year 2025."},{"ai_confidence":1.0,"created_at":"2026-04-23T20:07:53.137326","entity":"FDA","event_type":"regulatory","id":"56807fab-474a-4932-b5b2-77edcfc0dcfc","impact":"low","pub_date":"2023-01-01","source_url":"https://www.fda.gov/drugs/novel-drug-approvals-fda/new-drug-therapy-approvals-2022","summary":"The FDA's CDER published its annual report detailing new drug therapy approvals for the year 2022."},{"ai_confidence":0.9,"created_at":"2026-04-23T20:07:53.137317","entity":"Jefferies","event_type":"announcement","id":"25d0eaa5-b2da-497c-b487-fa90f0826677","impact":"low","pub_date":"2025-01-01","source_url":"https://trial.medpath.com/news/44bed2cc87ddc99e/fda-breakthrough-therapy-designation-shows-72-approval-success-rate-in-decade-long-analysis","summary":"A Jefferies analysis revealed that 72% of FDA Breakthrough Therapy Designations from 2013-2022 ultimately led to drug approval."},{"ai_confidence":0.8,"created_at":"2026-04-23T20:07:53.137309","entity":"GoodRx","event_type":"announcement","id":"7904e1eb-508a-4a6c-b4ad-b5d1bac46dc5","impact":"low","pub_date":"2025-12-31","source_url":"https://www.goodrx.com/drugs/news/upcoming-fda-approvals?srsltid=AfmBOoqX4k7vGEStJfOJVxpoi_hPSAcgwV7n27CHpF_PVLP3Kn-asIWv","summary":"GoodRx reported on several highly anticipated treatments, including CagriSema and Anaphylm, expected to receive FDA approval in 2026."},{"ai_confidence":1.0,"created_at":"2026-04-23T20:07:53.137299","entity":"Beren Therapeutics P.B.C","event_type":"regulatory","id":"1a99ed61-136c-4178-ace9-45954e2a1c9b","impact":"medium","pub_date":"2025-12-10","source_url":"https://www.biospace.com/press-releases/fda-grants-breakthrough-therapy-designation-to-investigational-drug-adrabetadex-for-individuals-with-infantile-onset-niemann-pick-disease-type-c","summary":"Beren Therapeutics' investigational drug Adrabetadex received FDA Breakthrough Therapy Designation for infantile-onset Niemann-Pick Disease Type C."},{"ai_confidence":1.0,"created_at":"2026-04-23T20:07:53.137282","entity":"FDA","event_type":"regulatory","id":"f33d7027-a179-4ef7-b2bc-fcadf171d7e7","impact":"high","pub_date":"2025-12-31","source_url":"https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025","summary":"The FDA's CDER approved 46 novel drugs in 2025, significantly expanding treatment options in the U.S."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291930","entity":"roflumilast cream","event_type":"regulatory","id":"c45e4946-ca25-4081-aee5-b57baf8e7d42","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.hcplive.com/view/q2-2026-preview-6-fda-decisions-to-watch","summary":"Upcoming FDA decision for roflumilast cream for pediatric plaque psoriasis expected in Q2 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291924","entity":"baxdrostat","event_type":"regulatory","id":"e0debace-8379-4b54-8c57-b2278e8302bb","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.hcplive.com/view/q2-2026-preview-6-fda-decisions-to-watch","summary":"Upcoming FDA decision for baxdrostat for hypertension expected in Q2 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291917","entity":"olezarsen","event_type":"regulatory","id":"356a6fae-bd1b-4098-8b18-3e6a13de8d72","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.hcplive.com/view/q2-2026-preview-6-fda-decisions-to-watch","summary":"Upcoming FDA decision for olezarsen for severe hypertriglyceridemia expected in Q2 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291910","entity":"cytisinicline","event_type":"regulatory","id":"57abe1bd-25a4-4f72-98d1-e404db5fb8b4","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.hcplive.com/view/q2-2026-preview-6-fda-decisions-to-watch","summary":"Upcoming FDA decision for cytisinicline for smoking cessation expected in Q2 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291903","entity":"inhaled insulin","event_type":"regulatory","id":"0865c31a-4ecb-46a9-9ff2-8eb9a7ab3731","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.hcplive.com/view/q2-2026-preview-6-fda-decisions-to-watch","summary":"Upcoming FDA decision for inhaled insulin for pediatric patients expected in Q2 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291884","entity":"sparsentan","event_type":"regulatory","id":"a45ffc5e-9eed-45e7-9036-0a6ed2d95040","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.hcplive.com/view/q2-2026-preview-6-fda-decisions-to-watch","summary":"Upcoming FDA decision for sparsentan in focal segmental glomerulosclerosis expected in Q2 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.291877","entity":"Praxis Precision Medicines","event_type":"regulatory","id":"3afa01c1-3ba6-414b-97ee-dcdd25490dbb","impact":"high","pub_date":"2026-03-01","source_url":"https://www.stocktitan.net/news/PRAX/praxis-precision-medicines-announces-fda-acceptance-and-priority-p83rejsk7rol.html","summary":"Praxis Precision Medicines announced FDA acceptance and priority review of NDA for relutrigine for SCN2A and SCN8A DEEs."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.291870","entity":"Egetis Therapeutics","event_type":"regulatory","id":"fd20accc-0a07-49cd-b066-4fa0e8877cc5","impact":"high","pub_date":"2026-03-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQGl5ssk-heTGQqP8YXo3E1CW2sAP3UWYWKLfMg-hNm4pxJi43kfSVJ1mFHioeiqFULJUQ2alO4WPi2qCc75LbJHsJJvJ3_iUrAY0ZdR2TbXn0jyRHGu5zG17KPhSUaTgDEXWziVB1MJegyHAoFKM0xywV_uVL4BU2SGLgt_F4gg6bi81kRwD7thG2RPXW2PRkNG0eamx9Vg0EEL7uK4UMmmm6Y3BaMnyvC3pIcL-dfrt_LZG3qn2UYDe8tE2ja-WUDeT2ud_tz8l_ISgg==","summary":"Egetis Therapeutics announced FDA acceptance and priority review of NDA for Emcitate (tiratricol) for MCT8 deficiency."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291863","entity":"RP1","event_type":"regulatory","id":"230bac47-846a-41ec-812d-b638fa3bfd43","impact":"medium","pub_date":"2026-04-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQEsZdQgnNjTd_3P40ZY4-377QMNjfDSDWieJrh33E4Kq42hI78TsgFm96FHCaCSyNGcpbCmLNiExCKjzS0LYMIrm5dEyaSeldRsOGmYRX5s-IVGtyufvDrnHxdFvzlZlGoil5tdPArQiWs4IUOohyiG_1Qh_03IZWryiu5AZF-B7hD6ucYHFOz2","summary":"Upcoming FDA complete response letter for RP1 in advanced melanoma expected in Q2 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291855","entity":"trastuzumab deruxtecan","event_type":"regulatory","id":"ef15ade4-b81f-4ecd-b44b-51843b552c5d","impact":"medium","pub_date":"2026-04-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQEsZdQgnNjTd_3P40ZY4-377QMNjfDSDWieJrh33E4Kq42hI78TsgFm96FHCaCSyNGcpbCmLNiExCKjzS0LYMIrm5dEyaSeldRsOGmYRX5s-IVGtyufvDrnHxdFvzlZlGoil5tdPArQiWs4IUOohyiG_1Qh_03IZWryiu5AZF-B7hD6ucYHFOz2","summary":"Upcoming FDA decision on sBLA for trastuzumab deruxtecan in HER2-positive early breast cancer expected in Q2 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291833","entity":"vepdegestrant","event_type":"regulatory","id":"7fdbe694-6f84-4976-942d-034f07046b8a","impact":"medium","pub_date":"2026-04-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQEsZdQgnNjTd_3P40ZY4-377QMNjfDSDWieJrh33E4Kq42hI78TsgFm96FHCaCSyNGcpbCmLNiExCKjzS0LYMIrm5dEyaSeldRsOGmYRX5s-IVGtyufvDrnHxdFvzlZlGoil5tdPArQiWs4IUOohyiG_1Qh_03IZWryiu5AZF-B7hD6ucYHFOz2","summary":"Upcoming FDA decision on NDA for vepdegestrant for ESR1-mutant breast cancer expected in Q2 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291813","entity":"sonrotoclax","event_type":"regulatory","id":"1afd5267-4ab6-41bf-a95f-f242e42d81a0","impact":"medium","pub_date":"2026-04-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQEsZdQgnNjTd_3P40ZY4-377QMNjfDSDWieJrh33E4Kq42hI78TsgFm96FHCaCSyNGcpbCmLNiExCKjzS0LYMIrm5dEyaSeldRsOGmYRX5s-IVGtyufvDrnHxdFvzlZlGoil5tdPArQiWs4IUOohyiG_1Qh_03IZWryiu5AZF-B7hD6ucYHFOz2","summary":"Upcoming FDA decision on NDA for sonrotoclax in relapsed/refractory mantle cell lymphoma expected in Q2 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.291806","entity":"Elevar Therapeutics","event_type":"regulatory","id":"b4c6bcd8-93be-485a-ba27-bcf97f0948ce","impact":"high","pub_date":"2026-03-01","source_url":"https://www.onclive.com/view/fda-grants-priority-review-to-lirafugratinib-for-fgfr2-pretreated-cholangiocarcinoma","summary":"FDA granted priority review to Elevar Therapeutics' NDA for lirafugratinib for pretreated cholangiocarcinoma, with a PDUFA date of Sept 27, 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.291799","entity":"Soficabtagene geleucel (WU-CART-007)","event_type":"regulatory","id":"434dd05c-bfae-4a5e-b6da-cd2ef60851ef","impact":"high","pub_date":"2026-03-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQGe9agtljSOsT0tQmLWsA26N0dRrR0_YQMdn_SoLkIcVwIkhPYKKV7U59KGjGddF4YUr4gwiXzPxVx5nxqkd59WS9yDaHoyypLDzi_HuhBrXdumdq-H-8__Sl5CJqH-1WwG2LVnwJWugiCCK5yMUQxjMzGybQ3ooNAETvr1bXep9jJAeIC1BdyE3kJjBRIS7IBmRlPqgjEvHBwTPBk7LWJJb5AD8-oPJqoukkRY-ZUVLfZ8ksTT30TC6jECPEE=","summary":"FDA granted Breakthrough Therapy Designation to Soficabtagene geleucel (WU-CART-007) for relapsed or refractory T-cell leukemia and lymphoma."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291790","entity":"FDA","event_type":"announcement","id":"1134927d-c96b-4572-89a2-0f7974aacfe7","impact":"medium","pub_date":"2026-03-01","source_url":"https://www.medpagetoday.com/publichealthpolicy/fdageneral/120604","summary":"FDA Commissioner Marty Makary announced that speeding up drug approvals and increasing OTC drug availability are key agency priorities."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.291761","entity":"trastuzumab deruxtecan","event_type":"regulatory","id":"db250571-94c1-49be-a0e3-8f44b54a7350","impact":"high","pub_date":"2026-03-01","source_url":"https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-march-2026","summary":"FDA fast-tracked and granted priority review to trastuzumab deruxtecan for HER2-positive early breast cancer in March 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.291726","entity":"rusfertide","event_type":"regulatory","id":"deafdbb2-f7d3-48d8-a925-b44a178e934c","impact":"high","pub_date":"2026-03-01","source_url":"https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-march-2026","summary":"FDA fast-tracked and granted priority review to rusfertide for polycythemia vera in March 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.290500","entity":"lirafugratinib","event_type":"regulatory","id":"dd3c7813-8e56-48a4-8d76-7cf6cccd52e8","impact":"high","pub_date":"2026-03-01","source_url":"https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-march-2026","summary":"FDA fast-tracked and granted priority review to lirafugratinib for cholangiocarcinoma in March 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.290493","entity":"luvesilocin","event_type":"regulatory","id":"175a403c-64b8-4c86-86c3-a70451c115f8","impact":"high","pub_date":"2026-03-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQEZAvWP00QpRR-39U-gT_5-IiZP5jTRg37Z6s4ch47WXH7zC3UbrGLBQp3aQ_IjAgCsLUAnPhpzJyOoBxTDvyydwlRveYZjFniMkFR2okSjL-XXuECYlqVjx9FlOWkBckIKnOfWu1iYvHN_epj1y_mx230r9btzRkqqEDF","summary":"FDA granted Breakthrough Therapy Designation to luvesilocin for postpartum depression (PPD)."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.290486","entity":"milsaperidone","event_type":"regulatory","id":"34f3256e-730c-4dd2-ac70-2ca7a0cde590","impact":"high","pub_date":"2026-03-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQEZAvWP00QpRR-39U-gT_5-IiZP5jTRg37Z6s4ch47WXH7zC3UbrGLBQp3aQ_IjAgCsLUAnPhpzJyOoBxTDvyydwlRveYZjFniMkFR2okSjL-XXuECYlqVjx9FlOWkBckIKnOfWu1iYvHN_epj1y_mx230r9btzRkqqEDF","summary":"FDA approved milsaperidone for schizophrenia and bipolar 1."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.290479","entity":"Avlayah","event_type":"regulatory","id":"37b34aba-aa91-4113-a383-abe5aa6f7cba","impact":"high","pub_date":"2026-03-01","source_url":"https://www.drugs.com/newdrugs.html","summary":"FDA approved Avlayah for Hunter Syndrome in 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.290472","entity":"Lifyorli","event_type":"regulatory","id":"9e3573e7-2b87-48d0-9090-be429858010f","impact":"high","pub_date":"2026-03-01","source_url":"https://www.drugs.com/newdrugs.html","summary":"FDA approved Lifyorli for platinum-resistant ovarian cancer in 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.290464","entity":"Awiqli (insulin icodec-abae)","event_type":"regulatory","id":"69b740d2-679b-4949-8432-2d18a10474a9","impact":"high","pub_date":"2026-03-01","source_url":"https://www.drugs.com/newdrugs.html","summary":"FDA approved Awiqli (insulin icodec-abae) for type 2 diabetes in 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.290437","entity":"Kresladi (marnetegragene autotemcel)","event_type":"regulatory","id":"50b46620-1159-4ef2-b0ed-782e55f9de9c","impact":"high","pub_date":"2026-03-01","source_url":"https://www.drugs.com/newdrugs.html","summary":"FDA approved Kresladi (marnetegragene autotemcel) for severe Leukocyte Adhesion Deficiency-I in 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.290431","entity":"Foundayo (orforglipron)","event_type":"regulatory","id":"561a40a7-aeae-46b4-b1fe-70fad00ebdd9","impact":"high","pub_date":"2026-03-01","source_url":"https://www.drugs.com/newdrugs.html","summary":"FDA approved Foundayo (orforglipron) for weight loss in 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.290424","entity":"Eli Lilly","event_type":"regulatory","id":"4bf65928-5669-4e29-b00d-cf7c4d399481","impact":"high","pub_date":"2026-03-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQH3Vzu7dIG5Z8I__BCUcnFA7VRdtEebvf48OYvlniJfNGCaMGPnFLkkrLKFA-hEhD8nWNaqH_YwU5Jo6OiasR0kxJBMKkLzSXAQ2pEBC40SEqnxLk-VPeoDysvy3EodhWFZpWrYmEf9ZKncZZhSk8I59M_8OMX5D3ugzCUUR1p1SrhausaxN_vfl5zsa90n4lcT2vLDKCTaLpaLaa032mvS-SJ-UMGVRQt6QMpMUTMeZL2gZUaho6lH76cDhS_3g==","summary":"FDA approved Eli Lilly's Foundayo (orforglipron) for weight management under the National Priority Voucher program."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.290418","entity":"leucovorin","event_type":"regulatory","id":"31e07b93-b2bb-4ac2-b480-3d742eb55500","impact":"medium","pub_date":"2026-03-01","source_url":"https://www.neurologylive.com/view/fda-action-update-march-2026-lift-on-crl-expanded-approvals-and-priority-review","summary":"FDA approved expanded use of leucovorin for cerebral folate transport deficiency in March 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.290410","entity":"tividenofusp alfa","event_type":"regulatory","id":"3747ebc0-0cd1-42ff-b527-67996bf7f13e","impact":"high","pub_date":"2026-03-01","source_url":"https://www.neurologylive.com/view/fda-action-update-march-2026-lift-on-crl-expanded-approvals-and-priority-review","summary":"FDA granted accelerated approval to tividenofusp alfa for Hunter syndrome in March 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.290402","entity":"Ionis Pharmaceuticals","event_type":"regulatory","id":"0e37374d-a5df-4363-97ed-34709239a49b","impact":"high","pub_date":"2026-03-01","source_url":"https://www.neurologylive.com/view/fda-action-update-march-2026-lift-on-crl-expanded-approvals-and-priority-review","summary":"FDA accepted Ionis Pharmaceuticals' zilganersen NDA for priority review in Alexander disease in March 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.290371","entity":"Capricor","event_type":"regulatory","id":"52eaabf0-d283-435d-b433-c60e347a43cc","impact":"medium","pub_date":"2026-03-01","source_url":"https://www.neurologylive.com/view/fda-action-update-march-2026-lift-on-crl-expanded-approvals-and-priority-review","summary":"FDA lifted a complete response letter (CRL) for Capricor's deramiocel in March 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.290347","entity":"FORE Biotherapeutics","event_type":"regulatory","id":"aebd6212-1f6d-4d30-8903-19e17dddea37","impact":"high","pub_date":"2026-03-01","source_url":"https://fore.bio/fore-biotherapeutics-receives-breakthrough-therapy-designation-for-plixorafenib/","summary":"FDA granted Breakthrough Therapy Designation to FORE Biotherapeutics' plixorafenib for BRAF V600E-mutated high-grade glioma."},{"ai_confidence":0.95,"created_at":"2026-04-05T02:58:34.021685","entity":"Praxis Precision Medicines","event_type":"regulatory","id":"c0569807-2a03-4085-81c8-d418e390f8d5","impact":"medium","pub_date":"2026-04-01","source_url":"https://stocktitan.com/news/PRAX/praxis-precision-medicines-announces-fda-acceptance-and-priority-review-of-v2242131234.html","summary":"Praxis Precision Medicines announced FDA acceptance and Priority Review of its NDA for relutrigine for SCN2A and SCN8A DEEs, with a PDUFA date of September 27, 2026."},{"ai_confidence":0.85,"created_at":"2026-04-05T02:58:34.021679","entity":"FDA","event_type":"announcement","id":"bdfe305c-3c7f-492c-b864-10d32070b00d","impact":"low","pub_date":"2026-04-01","source_url":"https://www.biopharmadive.com/news/fda-turbulent-year-drugmakers-guessing-direction/712000/","summary":"Amidst a turbulent year, the FDA is emphasizing efforts to speed up drug approvals through programs like the national priority voucher."},{"ai_confidence":0.95,"created_at":"2026-04-05T02:58:34.021672","entity":"Cogent Biosciences","event_type":"regulatory","id":"57c4da46-b1b6-43a5-9ef6-988565fb0e84","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.globenewswire.com/news-release/2026/04/01/3820000/0/en/Cogent-Biosciences-Announces-Submission-of-New-Drug-Application-for-Bezuclastinib-in-Gastrointestinal-Stromal-Tumors-GIST.html","summary":"Cogent Biosciences submitted an NDA for bezuclastinib for Gastrointestinal Stromal Tumors (GIST) under the FDA's Real-Time Oncology Review program."},{"ai_confidence":0.95,"created_at":"2026-04-05T02:58:34.021665","entity":"BridgeBio Pharma","event_type":"regulatory","id":"84dc9236-0939-47c1-9d79-5de34a42bc5f","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.neurologylive.com/view/bridgebio-submits-nda-bbp-418-lgmd2i-r9-first-approved-therapy-limb-girdle-muscular-dystrophy","summary":"BridgeBio Pharma submitted an NDA to the FDA for BBP-418 for limb-girdle muscular dystrophy type 2I/R9, potentially the first therapy for any form of LGMD."},{"ai_confidence":0.9,"created_at":"2026-04-05T02:58:34.021658","entity":"FDA","event_type":"announcement","id":"8deac398-c3c4-450a-83b4-b82eacd44d10","impact":"low","pub_date":"2026-04-01","source_url":"https://www.medpagetoday.com/publichealthpolicy/fdageneral/109345","summary":"FDA Commissioner Marty Makary announced the agency's commitment to speeding up drug approvals and increasing over-the-counter medication availability."},{"ai_confidence":0.95,"created_at":"2026-04-05T02:58:34.021650","entity":"Egetis Therapeutics","event_type":"regulatory","id":"d7881036-8d1b-4584-8689-ca1044b5ccdb","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.biospace.com/article/egetis-announces-fda-acceptance-and-priority-review-of-nda-for-emcitate-r-tiratricol-for-mct8-deficiency/","summary":"Egetis Therapeutics announced FDA acceptance and Priority Review of its NDA for Emcitate (tiratricol) for MCT8 deficiency, with a PDUFA date of September 28, 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T02:58:34.021643","entity":"Fore Biotherapeutics","event_type":"regulatory","id":"5dc842a2-1f78-4759-b058-d37bd88e3fb6","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.targetedonc.com/view/fda-grants-breakthrough-therapy-designation-to-plixorafenib-for-braf-v600e-glioma","summary":"FDA granted Breakthrough Therapy Designation to Fore Biotherapeutics' plixorafenib for adult patients with BRAF V600E\u2013mutated high-grade glioma."},{"ai_confidence":0.95,"created_at":"2026-04-05T02:58:34.021636","entity":"Bristol Myers Squibb","event_type":"regulatory","id":"495bc1b7-0b56-49c0-a21c-6a17bca68dcf","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.soho.com/news/fda-accepts-nda-for-iberdomide-in-relapsed-refractory-myeloma","summary":"FDA accepted Bristol Myers Squibb's NDA for iberdomide for relapsed/refractory multiple myeloma, granting Breakthrough Therapy Designation and Priority Review."},{"ai_confidence":0.85,"created_at":"2026-04-05T02:58:34.021628","entity":"Eli Lilly","event_type":"regulatory","id":"3cf44135-e932-49c7-b91f-50ec20c54073","impact":"medium","pub_date":"2026-03-31","source_url":"https://www.biospace.com/article/6-fda-decisions-to-watch-in-q2-2026/","summary":"Eli Lilly's orforglipron received a Commissioner's National Priority Voucher, expediting its review process prior to its approval."},{"ai_confidence":0.95,"created_at":"2026-04-05T02:58:34.021618","entity":"Orchard Therapeutics","event_type":"regulatory","id":"d316acc4-3b0c-45ff-9210-7b97d9888004","impact":"high","pub_date":"2026-03-27","source_url":"https://www.drugs.com/new-drug-approvals/2026.html","summary":"FDA granted accelerated approval to Orchard Therapeutics' Kresladi (marnetegragene autotemcel) for severe Leukocyte Adhesion Deficiency-I."},{"ai_confidence":1.0,"created_at":"2026-04-05T02:58:34.021474","entity":"Eli Lilly","event_type":"regulatory","id":"8d9238ec-0215-43a4-abf2-90a12a126a3a","impact":"high","pub_date":"2026-04-01","source_url":"https://www.fda.gov/newsroom/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program","summary":"FDA approved Eli Lilly's Foundayo (orforglipron) for obesity and weight-related conditions in a record 50 days under a priority voucher program."},{"ai_confidence":0.9,"created_at":"2026-04-05T02:58:34.021359","entity":"FDA","event_type":"regulatory","id":"45d72f78-5ffe-4bbb-b811-7f573bf22b9a","impact":"medium","pub_date":"2026-03-01","source_url":"https://www.pharmacytimes.com/view/fda-action-update-march-2026-lift-on-crl-expanded-approvals-and-priority-review","summary":"FDA approved expanded use of leucovorin calcium tablets for cerebral folate transport deficiency, marking the first therapy for this rare condition."},{"ai_confidence":0.95,"created_at":"2026-04-05T02:58:34.021311","entity":"Ionis Pharmaceuticals","event_type":"regulatory","id":"d04cd17e-de5e-4122-bce7-c36f0e10deff","impact":"medium","pub_date":"2026-03-01","source_url":"https://www.pharmacytimes.com/view/fda-action-update-march-2026-lift-on-crl-expanded-approvals-and-priority-review","summary":"FDA accepted Ionis Pharmaceuticals' NDA for zilganersen for Alexander disease with priority review, setting a PDUFA date of September 22, 2026."}]