[{"ai_confidence":0.9,"created_at":"2026-05-30T06:33:08.326496","entity":"Capricor Therapeutics","event_type":"regulatory","id":"0a6cf21e-f0ab-4f7a-893d-0a2c10fa4327","impact":"medium","pub_date":"2026-08-22","source_url":"https://www.capricor.com/investors/news-events/press-releases/detail/341/capricor-therapeutics-announces-late-breaking-presentation","summary":"Capricor Therapeutics' BLA for Deramiocel in DMD is under FDA review with a PDUFA target action date of August 22, 2026."},{"ai_confidence":0.9,"created_at":"2026-05-30T06:33:08.326490","entity":"Capricor Therapeutics","event_type":"product","id":"b4c9720a-0992-4b11-93f0-9a5b86efdda3","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.capricor.com/investors/news-events/press-releases/detail/341/capricor-therapeutics-announces-late-breaking-presentation","summary":"Capricor Therapeutics presented positive Phase 3 HOPE-3 data for Deramiocel in DMD at the AAN 2026 Annual Meeting."},{"ai_confidence":1.0,"created_at":"2026-05-30T06:33:08.326483","entity":"Genmab","event_type":"regulatory","id":"a885c87a-de9c-4e44-8918-733067bd7ece","impact":"high","pub_date":"2025-08-07","source_url":"https://ir.genmab.com/news-releases/news-release-details/genmab-announces-phase-3-epcorer-fl-1-clinical-trial-met-dual","summary":"FDA accepted Genmab's sBLA for epcoritamab plus R2 for priority review, with a PDUFA action date of November 30, 2025."},{"ai_confidence":1.0,"created_at":"2026-05-30T06:33:08.326476","entity":"Genmab","event_type":"product","id":"7ae6c4fc-1697-4c0b-9cb9-9c0a6d7e87a8","impact":"high","pub_date":"2025-08-07","source_url":"https://ir.genmab.com/news-releases/news-release-details/genmab-announces-phase-3-epcorer-fl-1-clinical-trial-met-dual","summary":"Genmab's Phase 3 EPCORE FL-1 trial for epcoritamab in R/R Follicular Lymphoma met dual primary endpoints with significant improvement."},{"ai_confidence":0.9,"created_at":"2026-05-30T06:33:08.326451","entity":"Developer of Veligrotug","event_type":"regulatory","id":"800caacc-d34c-4794-9a38-ff52f530e81b","impact":"medium","pub_date":"2026-06-01","source_url":"https://conexiant.com/infectious-disease/articles/fda-monthly-preview-key-june-decisions-to-watch/","summary":"Developer of veligrotug for thyroid eye disease has a PDUFA target action date in June 2026, based on positive Phase III data."},{"ai_confidence":0.9,"created_at":"2026-05-30T06:33:08.325875","entity":"Developer of Ensitrelvir","event_type":"regulatory","id":"56233697-b1c8-4a66-87f4-a8f07e71670f","impact":"medium","pub_date":"2026-06-01","source_url":"https://conexiant.com/infectious-disease/articles/fda-monthly-preview-key-june-decisions-to-watch/","summary":"Developer of ensitrelvir for COVID-19 prevention has a PDUFA target action date in June 2026, based on Phase III results."},{"ai_confidence":0.9,"created_at":"2026-05-30T06:33:08.325841","entity":"Developer of Tebipenem HBr","event_type":"regulatory","id":"819a9914-1d14-4801-8ddf-8764c29cfcb3","impact":"medium","pub_date":"2026-06-01","source_url":"https://conexiant.com/infectious-disease/articles/fda-monthly-preview-key-june-decisions-to-watch/","summary":"Developer of tebipenem HBr for cUTIs has a PDUFA target action date in June 2026, supported by positive Phase III data."},{"ai_confidence":0.9,"created_at":"2026-05-29T06:18:30.862620","entity":"IntraBio","event_type":"regulatory","id":"92a39ff0-8064-4e99-9196-51765b37bdc2","impact":"high","pub_date":"2024-05-19","source_url":"https://www.ataxia.org/pharmanews/","summary":"FDA accepted IntraBio's sNDA for AQNEURSA (levacetylleucine) for Ataxia-Telangiectasia and granted it Priority Review."},{"ai_confidence":1.0,"created_at":"2026-05-29T06:18:30.862612","entity":"AstraZeneca","event_type":"regulatory","id":"d35455d8-c2a2-46b2-964f-9d9e02563143","impact":"medium","pub_date":"2024-05-20","source_url":"https://www.pharmabiz.com/NewsDetails.aspx?aid=162238&sid=2","summary":"FDA extended PDUFA for AstraZeneca's camizestrant NDA for breast cancer, seeking more data after a negative advisory vote."},{"ai_confidence":1.0,"created_at":"2026-05-29T06:18:30.862584","entity":"Zydus Therapeutics","event_type":"regulatory","id":"85d49aa1-c562-4514-8432-c0083b39be96","impact":"high","pub_date":"2024-05-20","source_url":"https://www.prnewswire.com/news-releases/zydus-therapeutics-new-drug-application-nda-for-saroglitazar-to-treat-primary-biliary-cholangitis-pbc-granted-priority-review-by-the-us-fda-302464499.html","summary":"FDA granted Priority Review for Zydus Therapeutics' saroglitazar NDA for PBC, setting a PDUFA date of November 27, 2026."},{"ai_confidence":1.0,"created_at":"2026-05-28T06:03:09.805133","entity":"Summit Therapeutics","event_type":"regulatory","id":"227e62bc-47d3-4290-b040-bac74489290b","impact":"high","pub_date":"2026-01-29","source_url":"https://www.businesswire.com/news/home/20260129109846/en/Summit-Therapeutics-Announces-U.S.-FDA-Acceptance-of-Biologics-License-Application-BLA-Seeking-Approval-for-Ivonescimab-in-Combination-with-Chemotherapy-in-Treatment-of-Patients-with-EGFRm-NSCLC-Post-TKI-Therapy","summary":"Summit Therapeutics announced FDA acceptance of its BLA for ivonescimab for EGFRm NSCLC, setting a PDUFA goal date of November 14, 2026."},{"ai_confidence":0.9,"created_at":"2026-05-28T06:03:09.805118","entity":"Pfizer","event_type":"product","id":"b5fe7d24-9b19-413d-9be4-bcc82f109a39","impact":"medium","pub_date":"2026-01-29","source_url":"https://www.biopharmadive.com/news/asco-2026-abstracts-merck-biontech-lilly-moderna/820898/","summary":"Pfizer's SSGJ-707 showed a 68% response rate in a key subgroup of non-small cell lung cancer patients in anticipated ASCO26 data."},{"ai_confidence":0.98,"created_at":"2026-05-27T05:48:31.129572","entity":"Rocket Pharmaceuticals, Inc.","event_type":"regulatory","id":"1b1d249c-b0f0-4c9c-b75a-69c4c8e765e7","impact":"high","pub_date":"2025-10-14","source_url":"https://ir.rocketpharma.com/news-releases/news-release-details/rocket-pharmaceuticals-announces-fda-acceptance-bla-resubmission","summary":"Rocket Pharmaceuticals announced FDA acceptance of its BLA resubmission for KRESLADI\u2122 for severe LAD-I, with a PDUFA date of March 28, 2026."},{"ai_confidence":0.95,"created_at":"2026-05-27T05:48:31.129549","entity":"ImmunityBio","event_type":"regulatory","id":"8d3c584a-a9a1-4461-91dd-2dfe9428c156","impact":"medium","pub_date":"2024-05-15","source_url":"https://immunitybio.com/immunitybio-announces-resubmission-of-supplemental-bla-to-the-fda-for-anktiva-plus-bcg-in-bcg-unresponsive-nmibc-with-papillary-disease-following-agency-review-of-additional-data/","summary":"ImmunityBio resubmitted its supplemental BLA for ANKTIVA plus BCG for BCG-unresponsive NMIBC with papillary disease to the FDA."},{"ai_confidence":0.98,"created_at":"2026-05-27T05:48:31.129540","entity":"Orca Bio","event_type":"regulatory","id":"26fb3d6b-539d-44f7-833b-bd465fa07ee4","impact":"high","pub_date":"2025-10-06","source_url":"https://www.empr.com/news/fda-drug-approval-decisions-expected-in-april-2026/","summary":"The FDA set a PDUFA target action date of April 6, 2026, for Orca-T's BLA for hematological malignancies, granted Priority Review."},{"ai_confidence":0.95,"created_at":"2026-05-27T05:48:31.129526","entity":"FDA","event_type":"regulatory","id":"d14b1141-e96d-401f-8330-3e9a37d40d81","impact":"medium","pub_date":"2022-09-01","source_url":"https://www.fda.gov/media/151712/download","summary":"The FDA released PDUFA reauthorization performance goals and procedures for fiscal years 2023 through 2027, covering review, transparency, and drug safety."},{"ai_confidence":0.98,"created_at":"2026-05-27T05:48:31.129518","entity":"Ascletis Pharma Inc.","event_type":"product","id":"84ca6d59-7aed-4874-9230-b4a07772441b","impact":"medium","pub_date":"2025-06-01","source_url":"https://www.fdatracker.com/2025/06/phase-3-clinical-trials-with-primary-completion-dates-in-june-2025/","summary":"Ascletis Pharma's Phase 3 trial (NCT05118776) has a primary completion date of June 1, 2025."},{"ai_confidence":0.98,"created_at":"2026-05-27T05:48:31.129511","entity":"Apellis Pharmaceuticals, Inc.","event_type":"product","id":"db88d47e-e483-41f8-bfcc-17dfc81784c0","impact":"medium","pub_date":"2025-06-01","source_url":"https://www.fdatracker.com/2025/06/phase-3-clinical-trials-with-primary-completion-dates-in-june-2025/","summary":"Apellis Pharmaceuticals' Phase 3 trial for Pegcetacoplan Long Term Safety and Efficacy Extension Study has a primary completion date of June 1, 2025."},{"ai_confidence":0.95,"created_at":"2026-05-27T05:48:31.129502","entity":"FDA","event_type":"regulatory","id":"e040b7bd-e415-436c-b4b0-a433feca3306","impact":"medium","pub_date":"2026-05-01","source_url":"https://www.thefdalawblog.com/2026/05/fda-announces-new-real-time-clinical-trial-initiative-to-expedite-development-but-at-what-cost/","summary":"The FDA launched a new initiative for real-time clinical trials (RTCTs) to expedite development, including pilot programs and an RFI for AI-enabled technologies."},{"ai_confidence":0.95,"created_at":"2026-05-27T05:48:31.129485","entity":"FDA","event_type":"regulatory","id":"99276fd9-75f4-4add-9048-33841d650cea","impact":"medium","pub_date":"2024-05-15","source_url":"https://www.geneonline.com/fda-increasingly-approves-drugs-based-on-single-pivotal-trials-weighing-unmet-needs-and-long-term-safety/","summary":"The FDA is increasingly approving drugs based on single pivotal trials, considering disease severity, unmet need, trial design, and long-term safety."},{"ai_confidence":0.95,"created_at":"2026-05-26T05:33:08.222594","entity":"Priovant Therapeutics","event_type":"product","id":"fd5f2f9c-f1da-4e1d-88c3-a3dff05342b4","impact":"medium","pub_date":"2026-03-03","source_url":"https://investor.roivant.com/news-releases/news-release-details/priovant-announces-fda-acceptance-and-priority-review-new-drug","summary":"Priovant expects to launch brepocitinib in the United States at the end of September 2026, contingent on FDA approval."},{"ai_confidence":1.0,"created_at":"2026-05-26T05:33:08.222586","entity":"Priovant Therapeutics","event_type":"regulatory","id":"3f388137-13f0-4504-b92a-97ded5774db0","impact":"high","pub_date":"2026-03-03","source_url":"https://investor.roivant.com/news-releases/news-release-details/priovant-announces-fda-acceptance-and-priority-review-new-drug","summary":"Priovant announced FDA acceptance and Priority Review of its New Drug Application for brepocitinib in dermatomyositis, with a PDUFA date in Q3 2026."},{"ai_confidence":0.9,"created_at":"2026-05-26T05:33:08.222578","entity":"AstraZeneca","event_type":"product","id":"6536fd91-4b68-4f87-99b2-c5e037aea241","impact":"medium","pub_date":"2026-03-01","source_url":"https://www.miragenews.com/astrazeneca-unveils-phase-iii-cancer-rare-1678895/","summary":"AstraZeneca will present new Phase III data for Imfinzi/Imjudo and anselamimab at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2026."},{"ai_confidence":0.85,"created_at":"2026-05-26T05:33:08.222571","entity":"Akeso, Inc.","event_type":"product","id":"34ee951f-742a-4c04-a7c0-93511860f392","impact":"low","pub_date":"2026-03-01","source_url":"https://www.prnewswire.com/news-releases/health-latest-news/clinical-trials-medical-discoveries-list/","summary":"Akeso, Inc. announced that over 40 clinical studies of its oncology portfolio will be presented at the 2026 ASCO Annual Meeting."},{"ai_confidence":0.9,"created_at":"2026-05-26T05:33:08.222562","entity":"Caliway Biopharmaceuticals","event_type":"regulatory","id":"f6ba50fe-c7c8-4fc1-bb44-4f1d4b1ff581","impact":"medium","pub_date":"2026-03-01","source_url":"https://www.prnewswire.com/news-releases/health-latest-news/clinical-trials-medical-discoveries-list/","summary":"Caliway Biopharmaceuticals announced U.S. FDA IND Clearance for CBL-0302, enabling its second global pivotal Phase 3 Study of CBL-514."},{"ai_confidence":0.85,"created_at":"2026-05-26T05:33:08.222554","entity":"Hansa Biopharma","event_type":"product","id":"a2d800b5-c40a-4ea7-becb-bc112fea95f3","impact":"low","pub_date":"2026-03-01","source_url":"https://www.prnewswire.com/news-releases/health-latest-news/clinical-trials-medical-discoveries-list/","summary":"Hansa Biopharma announced a late-breaking abstract from its US Phase 3 ConfIdeS trial was selected for oral presentation at ATC 2026."},{"ai_confidence":0.9,"created_at":"2026-05-26T05:33:08.222544","entity":"FDA","event_type":"regulatory","id":"cdfe3915-59d3-4991-975c-26bc6f8588f3","impact":"low","pub_date":"2026-03-01","source_url":"https://www.raps.org/resource/this-week-at-fda-top-fdaers-ousted-vrbpac-to-review-moderna-flu-vaccine-pdufa-negotiations-concluded.html","summary":"The FDA updated its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot program for digital health devices with an educational module."},{"ai_confidence":0.9,"created_at":"2026-05-26T05:33:08.222526","entity":"FDA","event_type":"regulatory","id":"16b74549-7e1c-4acb-b3d7-50f8cff7f071","impact":"medium","pub_date":"2026-03-01","source_url":"https://www.raps.org/resource/this-week-at-fda-top-fdaers-ousted-vrbpac-to-review-moderna-flu-vaccine-pdufa-negotiations-concluded.html","summary":"The FDA concluded technical negotiations with drug industry groups regarding the next Prescription Drug User Fee Amendments (PDUFA VIII) deal."},{"ai_confidence":0.92,"created_at":"2026-05-25T05:17:23.418511","entity":"Vera Therapeutics","event_type":"product","id":"e24638f6-ba8b-4dfb-80b0-60de77e58461","impact":"medium","pub_date":"2024-01-04","source_url":"https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-completes-full-enrollment-pivotal-origin-phase","summary":"Vera Therapeutics completed full enrollment in its pivotal ORIGIN Phase 3 clinical trial, a key milestone for the program."},{"ai_confidence":0.95,"created_at":"2026-05-25T05:17:23.418503","entity":"ImmunityBio","event_type":"product","id":"bb4da86b-b2f0-4322-a70b-43a9592eb897","impact":"medium","pub_date":"2026-05-20","source_url":"https://app.bpiq.com/","summary":"ImmunityBio expects Phase 1/2 data readout for Anktiva/N-803 + AgenT-797 combo for Coccidioides Immitis Infection on May 20, 2026."},{"ai_confidence":0.88,"created_at":"2026-05-25T05:17:23.418494","entity":"AstraZeneca","event_type":"regulatory","id":"6eaca040-2718-486c-9ce2-196a8ee2ce10","impact":"high","pub_date":"2026-01-01","source_url":"https://www.goodrx.com/health-topic/fda-approvals/fda-approvals-new-drugs","summary":"AstraZeneca's Baxdrostat, a blood pressure medication, received priority review with an FDA decision expected in Q2 2026."},{"ai_confidence":0.98,"created_at":"2026-05-25T05:17:23.418484","entity":"FDA","event_type":"regulatory","id":"9b86f8b9-4835-4466-94c9-81ad80ad9712","impact":"high","pub_date":"2022-09-30","source_url":"https://www.fda.gov/drugs/prescription-drug-user-fee-act/fda-track-prescription-drug-user-fee-act-pdufa-performance-reports","summary":"The FDA's PDUFA was reauthorized for five years (FY 2023-2027) on September 30, 2022, enhancing drug review efficiency."},{"ai_confidence":0.85,"created_at":"2026-05-25T05:17:23.418442","entity":"FDA","event_type":"regulatory","id":"7079e622-7159-4e10-8662-36685b888b99","impact":"low","pub_date":"2025-09-30","source_url":"https://www.fda.gov/drugs/prescription-drug-user-fee-act/fda-track-prescription-drug-user-fee-act-pdufa-performance-dashboards","summary":"FDA released PDUFA Performance Dashboards providing insights into drug application review data for fiscal years 2024-2026."},{"ai_confidence":0.95,"created_at":"2026-05-25T05:17:23.418339","entity":"FDA","event_type":"regulatory","id":"0e796c0b-70e0-45c0-81fd-465d35914535","impact":"medium","pub_date":"2026-04-20","source_url":"https://www.fda.gov/drugs/prescription-drug-user-fee-act/prescription-drug-user-fee-act-pdufa-reauthorization","summary":"FDA held a PDUFA VIII reauthorization meeting on April 20, 2026, discussing proposed changes with stakeholders."},{"ai_confidence":1.0,"created_at":"2026-05-24T05:04:16.584373","entity":"Celcuity Inc.","event_type":"product","id":"bfdda89c-7889-4bb7-b665-cd5eda74b9dd","impact":"high","pub_date":"2026-05-01","source_url":"https://ir.celcuity.com/news-releases/news-release-details/celcuitys-phase-3-viktoria-1-trial-achieves-primary-endpoint","summary":"Celcuity's Phase 3 VIKTORIA-1 trial achieved its primary endpoint, showing improved progression-free survival in PIK3CA mutant breast cancer."},{"ai_confidence":1.0,"created_at":"2026-05-24T05:04:16.584365","entity":"Apellis Pharmaceuticals","event_type":"regulatory","id":"efead061-e263-483d-9ed4-a2dec27f478c","impact":"medium","pub_date":"2020-11-16","source_url":"https://investors.apellis.com/news-releases/news-release-details/apellis-announces-fda-acceptance-and-priority-review-new-drug","summary":"Apellis announced FDA acceptance and priority review of its New Drug Application for pegcetacoplan for PNH, with a PDUFA date of May 14, 2021."},{"ai_confidence":1.0,"created_at":"2026-05-24T05:04:16.584355","entity":"ImmunityBio","event_type":"regulatory","id":"01e7549a-ed76-4104-b8b0-16b4cdddab68","impact":"medium","pub_date":"2026-05-19","source_url":"https://www.morningstar.com/news/business-wire/20260519760562/immunitybio-announces-fda-acceptance-of-supplemental-bla-for-anktiva-plus-bcg-in-bcg-unresponsive-non-muscle-invasive-bladder-cancer-with-papillary-disease-pdufa-date-set-for-january-6-2027","summary":"ImmunityBio announced FDA accepted its supplemental Biologics License Application for ANKTIVA\u00ae plus BCG for bladder cancer, with a PDUFA date of Jan 6, 2027."},{"ai_confidence":0.9,"created_at":"2026-05-24T05:04:16.584334","entity":"BAXFENDY","event_type":"regulatory","id":"467b6273-b2b9-4929-bfb2-75acbb523892","impact":"high","pub_date":"2026-05-18","source_url":"https://www.businesswire.com/news/home/20260518258445/en/BAXFENDY-approved-in-the-US-as-the-first-and-only-aldosterone-synthase-inhibitor-treatment-for-adults-with-hypertension","summary":"BAXFENDY received FDA approval in the US as the first and only aldosterone synthase inhibitor treatment for adults with hypertension."},{"ai_confidence":1.0,"created_at":"2026-05-24T05:04:16.584199","entity":"Viatris","event_type":"regulatory","id":"d05e5e92-ed9b-444e-a54c-4b9a60d8ae74","impact":"medium","pub_date":"2026-05-18","source_url":"https://newsroom.viatris.com/2026-05-18-U-S-FDA-Accepts-Viatris-New-Drug-Application-for-Fast-Acting-Meloxicam-for-the-Treatment-of-Moderate-to-Severe-Acute-Pain","summary":"FDA accepted Viatris's New Drug Application for fast-acting meloxicam for moderate-to-severe acute pain, setting a PDUFA date of Dec 27, 2026."},{"ai_confidence":0.95,"created_at":"2026-05-23T04:46:25.053734","entity":"BioMarin","event_type":"product","id":"db1e2bc6-f03a-400e-9a37-b5d72d16ff09","impact":"medium","pub_date":"2024-05-20","source_url":"https://www.stocktitan.net/news/BMRN/biomarin-provides-update-on-phase-3-trial-for-bmn-401-in-children-aged-1-12-with-enpp1-deficiency-7999911.html","summary":"BioMarin's BMN 401 Phase 3 trial for ENPP1 deficiency met one co-primary endpoint but missed another, with no new safety signals."},{"ai_confidence":0.9,"created_at":"2026-05-23T04:46:25.053724","entity":"N/A","event_type":"regulatory","id":"dcff50c0-08f3-45c1-a557-19aa1b0d925a","impact":"high","pub_date":"2026-05-18","source_url":"https://www.businesswire.com/news/home/20260518005284/en/BAXFENDY-approved-in-the-US-as-the-first-and-only-aldosterone-synthase-inhibitor-treatment-for-adults-with-hypertension","summary":"BAXFENDY received FDA approval as the first aldosterone synthase inhibitor for adults with hypertension, based on positive Phase III trial results."},{"ai_confidence":0.95,"created_at":"2026-05-23T04:46:25.053703","entity":"ImmunityBio","event_type":"regulatory","id":"b1deb9fc-1b11-4684-ab53-7d12d187909e","impact":"medium","pub_date":"2024-05-20","source_url":"https://www.biospace.com/article/immunitybio-announces-fda-acceptance-of-supplemental-bla-for-anktiva-reg-plus-bcg-in-bcg-unresponsive-non-muscle-invasive-bladder-cancer-with-papillary-disease-pdufa-date-set-for-january-6-2027/","summary":"FDA accepted ImmunityBio's sBLA for ANKTIVA\u00ae plus BCG for bladder cancer, setting a PDUFA date of January 6, 2027."},{"ai_confidence":0.98,"created_at":"2026-05-22T04:31:49.941667","entity":"Novo Nordisk","event_type":"regulatory","id":"34e727c3-fc5d-4fe3-b967-9cd125df9d2a","impact":"medium","pub_date":"2025-12-01","source_url":"https://www.milliman.com/en/insight/4-pending-fda-approvals-payers-pbms-market-access-teams","summary":"Novo Nordisk filed an NDA in December 2025 for CagriSema, targeting adults with obesity or overweight, with FDA approval expected through early 2027."},{"ai_confidence":0.98,"created_at":"2026-05-22T04:31:49.941659","entity":"Praxis Precision Medicines","event_type":"regulatory","id":"739f321c-680c-4bf6-8da2-83f9c615f0b9","impact":"medium","pub_date":"2026-02-01","source_url":"https://www.milliman.com/en/insight/4-pending-fda-approvals-payers-pbms-market-access-teams","summary":"Praxis Precision Medicines submitted an NDA in February 2026 for ulixacaltamide, for essential tremor, with FDA approval expected through early 2027."},{"ai_confidence":0.95,"created_at":"2026-05-22T04:31:49.941650","entity":"FDA","event_type":"regulatory","id":"096fbf09-d03b-4ca6-a52e-0525d47d94fa","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.hcplive.com/view/q2-2026-preview-6-fda-decisions-to-watch","summary":"FDA expects Q2 2026 decisions on six therapies: sparsentan, inhaled insulin, cytisinicline, olezarsen, baxdrostat, and roflumilast."},{"ai_confidence":0.98,"created_at":"2026-05-22T04:31:49.941637","entity":"FDA","event_type":"regulatory","id":"577cdbe9-0607-4cd6-bd28-79294bebc022","impact":"medium","pub_date":"2026-04-20","source_url":"https://www.fda.gov/media/192546/download","summary":"The FDA held its sixth PDUFA VIII Reauthorization meeting on April 20, 2026, discussing proposed refinements for efficiency and safety standards."},{"ai_confidence":0.95,"created_at":"2026-05-22T04:31:49.941619","entity":"Small-cap biotech companies","event_type":"product","id":"adddfc02-e52e-41db-a970-8dd54eb57d07","impact":"low","pub_date":"2026-01-01","source_url":"https://www.fdatracker.com/2026/05/phase-3-clinical-trials-with-primary-completion-dates-in-may-2026/","summary":"A tracker identified Phase 3 clinical trials for small-cap biotech companies with primary completion dates in May 2026, signaling upcoming results."},{"ai_confidence":0.95,"created_at":"2026-05-21T04:16:45.098631","entity":"UroGen Pharma Ltd.","event_type":"product","id":"3db8a023-6175-4c51-b776-8395b33246e7","impact":"high","pub_date":"2026-05-15","source_url":"https://www.biospace.com/article/press-releases/urogen-reports-94-5-percent-six-month-duration-of-response-in-phase-3-utopia-trial-advancing-ugn-103-toward-potential-approval-in-recurrent-low-grade-intermediate-risk-nmibc/","summary":"UroGen Pharma Ltd. reported positive Phase 3 UTOPIA trial results for UGN-103, showing a 94.5% six-month duration of response."},{"ai_confidence":0.95,"created_at":"2026-05-21T04:16:45.098624","entity":"Savara","event_type":"product","id":"de25761e-d9c2-40e2-95b8-857ec8055e02","impact":"high","pub_date":"2026-05-20","source_url":"https://www.biospace.com/article/press-releases/savara-presented-long-term-efficacy-and-safety-data-from-the-ongoing-impala-2-phase-3-clinical-trial-open-label-ol-extension-of-molgramostim-inhalation-solution-molgramostim-in-autoimmune-pulmonary-alveolar-proteinosis-apap/","summary":"Savara presented long-term efficacy and safety data from the ongoing IMPALA-2 Phase 3 clinical trial extension of Molgramostim."},{"ai_confidence":0.9,"created_at":"2026-05-21T04:16:45.098616","entity":"FDA","event_type":"regulatory","id":"ea739da1-75f2-469a-af60-93986c138efe","impact":"medium","pub_date":"2026-05-15","source_url":"https://www.mintz.com/insights-center/viewpoints/2791/2026-05-15-fda-flux-may-2026-newsletter","summary":"The FDA proposed not to include semaglutide, tirzepatide, and liraglutide on the list of ingredients for outsourcing facilities to use for compounding."},{"ai_confidence":0.9,"created_at":"2026-05-21T04:16:45.098608","entity":"FDA","event_type":"regulatory","id":"bfc75b86-7888-4e9c-a76a-4b90e7814268","impact":"medium","pub_date":"2026-05-15","source_url":"https://www.mintz.com/insights-center/viewpoints/2791/2026-05-15-fda-flux-may-2026-newsletter","summary":"The FDA is exploring AI and real-time data to streamline clinical trials, initiating proof-of-concept 'real-time clinical trials' (RTCTs)."},{"ai_confidence":0.9,"created_at":"2026-05-21T04:16:45.098600","entity":"Galectin Therapeutics","event_type":"product","id":"c9534b2e-272d-4e65-b452-9ed8b10aefb7","impact":"high","pub_date":"2026-05-27","source_url":"https://biopharmiq-frontend.vercel.app/catalyst-calendar","summary":"Phase 2/3 data readout for Galectin Therapeutics' Belapectin (GR-MD-02) in non-alcoholic steatohepatitis is expected."},{"ai_confidence":0.85,"created_at":"2026-05-21T04:16:45.098591","entity":"Lipocine Inc.","event_type":"product","id":"3fcbc20f-71ed-49af-928c-2e9331a53422","impact":"high","pub_date":"2026-05-26","source_url":"https://biopharmiq-frontend.vercel.app/catalyst-calendar","summary":"Phase 3 data readout for Lipocine Inc.'s LPCN 1154 (Brexanolone) in postpartum depression is expected."},{"ai_confidence":0.9,"created_at":"2026-05-21T04:16:45.098574","entity":"Ironwood Pharmaceuticals and AbbVie","event_type":"regulatory","id":"79427791-43f1-4991-a381-6a0b8f0c6457","impact":"medium","pub_date":"2026-05-24","source_url":"https://biopharmiq-frontend.vercel.app/catalyst-calendar","summary":"A PDUFA decision for LINZESS FC in pediatric patients is expected from the FDA."},{"ai_confidence":0.9,"created_at":"2026-05-20T04:02:30.781995","entity":"Rigel Pharmaceuticals, Inc.","event_type":"partnership","id":"1e8d0260-174a-4358-a906-554f4feef073","impact":"high","pub_date":"2026-05-25","source_url":"https://www.rigel.com/investors/news-events/press-releases/detail/437/rigel-enters-exclusive-global-licensing-agreement-for","summary":"Rigel Pharmaceuticals entered an exclusive global licensing agreement with Arvinas and Pfizer for VEPPANU\u2122 (vepdegestrant) for breast cancer."},{"ai_confidence":0.9,"created_at":"2026-05-20T04:02:30.781986","entity":"Capricor Therapeutics","event_type":"regulatory","id":"8698315f-539e-4436-b20d-aa7ebac146de","impact":"high","pub_date":"2026-05-15","source_url":"https://www.capricor.com/investors/news-events/press-releases/detail/344/capricor-therapeutics-reports-first-quarter-2026-financial","summary":"Capricor Therapeutics' Deramiocel BLA is under FDA review with an August 22, 2026 PDUFA date, following successful Phase 3 trial results."},{"ai_confidence":0.9,"created_at":"2026-05-20T04:02:30.781973","entity":"ImmunityBio, Inc.","event_type":"regulatory","id":"e22610cb-1f94-4de7-ac91-569c734d0755","impact":"high","pub_date":"2026-05-20","source_url":"https://immunitybio.com/immunitybio-announces-fda-acceptance-of-supplemental-bla-for-anktiva-plus-bcg-in-bcg-unresponsive-non-muscle-invasive-bladder-cancer-with-papillary-disease-pdufa-date-set-for-january-6-2027/","summary":"ImmunityBio announced FDA acceptance of its sBLA for ANKTIVA\u00ae Plus BCG for bladder cancer, setting a PDUFA date of January 6, 2027."},{"ai_confidence":1.0,"created_at":"2026-05-20T04:02:30.781949","entity":"IntraBio Inc.","event_type":"regulatory","id":"570cde0c-b628-4a19-9990-cd98e55a6d0a","impact":"high","pub_date":"2026-05-19","source_url":"https://www.businesswire.com/news/home/20260519802425/en/FDA-Accepts-sNDA-and-Grants-Priority-Review-to-AQNEURSA-for-Ataxia-Telangiectasia","summary":"FDA accepted IntraBio's sNDA for AQNEURSA\u00ae for Ataxia-Telangiectasia, granting Priority Review with a PDUFA date of September 19, 2026."},{"ai_confidence":0.95,"created_at":"2026-05-18T03:31:31.841177","entity":"Ionis Pharmaceuticals","event_type":"regulatory","id":"f0a7690c-21f1-418e-afbf-92494e40a10b","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":"The FDA accepted Ionis Pharmaceuticals' zilganersen NDA for priority review in Alexander disease."},{"ai_confidence":0.95,"created_at":"2026-05-18T03:31:31.841169","entity":"Capricor","event_type":"regulatory","id":"837a4150-34b8-4ad3-a31f-b9d76f2ef69f","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":"The FDA lifted a complete response letter (CRL) for Capricor's deramiocel, advancing its regulatory pathway."},{"ai_confidence":0.9,"created_at":"2026-05-18T03:31:31.841160","entity":"Bristol Myers Squibb Co.","event_type":"product","id":"f782ee69-095f-469c-a460-3d7925dc1922","impact":"high","pub_date":"2026-01-01","source_url":"https://www.bioworld.com/user/login?referer=%2Fcontent%2Fphase3-data-2026","summary":"Bristol Myers Squibb Co.'s Camzyos showed statistically significant reduction in Valsalva left ventricular outflow tract gradient in a Phase III trial."},{"ai_confidence":0.9,"created_at":"2026-05-18T03:31:31.841142","entity":"Alumis Inc.","event_type":"product","id":"9ba4e196-51f5-4fe9-9162-98b636adbd69","impact":"high","pub_date":"2026-01-01","source_url":"https://www.bioworld.com/user/login?referer=%2Fcontent%2Fphase3-data-2026","summary":"Alumis Inc.'s Envudeucitinib met primary and secondary endpoints in a Phase III clinical trial for plaque psoriasis."},{"ai_confidence":0.95,"created_at":"2026-05-16T03:01:31.267711","entity":"Amgen","event_type":"product","id":"2263e4eb-14b0-43cb-b6fd-b6fd6d44433c","impact":"medium","pub_date":"2024-05-29","source_url":"https://www.fda.gov/news-events/press-announcements/fda-announces-major-steps-implement-real-time-clinical-trials","summary":"Amgen is participating in FDA's proof-of-concept trials for real-time data submission, supporting accelerated drug development."},{"ai_confidence":0.95,"created_at":"2026-05-16T03:01:31.267701","entity":"AstraZeneca","event_type":"product","id":"806afeaa-01fd-4cbe-a5de-91f94992e210","impact":"medium","pub_date":"2024-05-29","source_url":"https://www.fda.gov/news-events/press-announcements/fda-announces-major-steps-implement-real-time-clinical-trials","summary":"AstraZeneca is participating in FDA's proof-of-concept trials for real-time data submission, supporting accelerated drug development."},{"ai_confidence":0.95,"created_at":"2026-05-16T03:01:31.267683","entity":"FDA","event_type":"regulatory","id":"70b08da1-0b4a-4155-b1e4-1a8947887d09","impact":"high","pub_date":"2024-05-29","source_url":"https://www.fda.gov/news-events/press-announcements/fda-announces-major-steps-implement-real-time-clinical-trials","summary":"FDA launched a new regulatory initiative for real-time clinical trials, aiming to accelerate drug development processes."},{"ai_confidence":0.95,"created_at":"2026-05-15T02:46:19.999093","entity":"Savara","event_type":"product","id":"aef6712a-1e47-4821-9dfc-705343e9db4f","impact":"medium","pub_date":"2024-03-05","source_url":"https://www.merlintrader.com/three-2026-fda-decisions/","summary":"Savara's molgramostim, if approved, could become a reference product in autoimmune PAP, potentially replacing procedure-heavy care."},{"ai_confidence":0.98,"created_at":"2026-05-15T02:46:19.999084","entity":"Protagonist Therapeutics","event_type":"regulatory","id":"d53514e9-7c2f-4a16-8253-b47613b2484c","impact":"high","pub_date":"2024-03-05","source_url":"https://www.merlintrader.com/three-2026-fda-decisions/","summary":"Protagonist and Takeda announced FDA acceptance and Priority Review for rusfertide NDA, with a PDUFA goal date in Q3 2026."},{"ai_confidence":0.98,"created_at":"2026-05-15T02:46:19.999061","entity":"Unicycive Therapeutics","event_type":"regulatory","id":"ced54245-2485-47ab-ad2f-e76c6dd43099","impact":"medium","pub_date":"2024-03-05","source_url":"https://www.merlintrader.com/three-2026-fda-decisions/","summary":"Unicycive Therapeutics' OLC NDA resubmission is under FDA review with a PDUFA target action date of June 29, 2026."},{"ai_confidence":0.95,"created_at":"2026-05-15T02:46:19.998201","entity":"TransCelerate BioPharma","event_type":"regulatory","id":"f76a847f-bb9f-42f5-8215-5102d188f92a","impact":"medium","pub_date":"2024-03-05","source_url":"https://www.prnewswire.com/news-releases/transcelerate-and-fda-advance-collaboration-on-streamlined-safety-data-collection-to-accelerate-inclusion-of-pragmatic-elements-in-clinical-trials-302762139.html","summary":"TransCelerate BioPharma released a report on selective safety data collection, advancing collaboration with the FDA to streamline clinical trials."},{"ai_confidence":0.95,"created_at":"2026-05-14T02:32:02.626520","entity":"Corcept Therapeutics","event_type":"regulatory","id":"95f868fc-1b81-4d22-a0d4-94f1e5630fc5","impact":"high","pub_date":"2026-05-05","source_url":"https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2026","summary":"The FDA approved Lifyorli (relacorilant) for certain cancers in 2026."},{"ai_confidence":0.95,"created_at":"2026-05-14T02:32:02.626512","entity":"Novo Nordisk","event_type":"regulatory","id":"3ae9ec78-31eb-467d-99c4-0a589e13d1bb","impact":"high","pub_date":"2026-05-05","source_url":"https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2026","summary":"The FDA approved Awiqli (insulin icodec-abae) for type 2 diabetes in 2026."},{"ai_confidence":0.95,"created_at":"2026-05-14T02:32:02.626504","entity":"Eli Lilly","event_type":"regulatory","id":"ab8953bf-571d-4450-ad90-f524d5717b99","impact":"high","pub_date":"2026-05-05","source_url":"https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2026","summary":"The FDA approved Foundayo (orforglipron) for weight management in 2026."},{"ai_confidence":0.95,"created_at":"2026-05-14T02:32:02.626495","entity":"Merck, Gilead","event_type":"regulatory","id":"5a6c272f-2b2a-4460-b88b-2a1b7952406f","impact":"high","pub_date":"2026-05-05","source_url":"https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2026","summary":"The FDA approved Idvynso (doravirine and islatravir) for HIV-1 infection in 2026."},{"ai_confidence":0.95,"created_at":"2026-05-14T02:32:02.626487","entity":"Eli Lilly","event_type":"regulatory","id":"c732e1b0-de5f-46b4-865e-8e5e9a487908","impact":"high","pub_date":"2026-05-05","source_url":"https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2026","summary":"The FDA approved Veppanu (vepdegestrant) for certain types of breast cancer in 2026."},{"ai_confidence":0.95,"created_at":"2026-05-14T02:32:02.626479","entity":"AbbVie","event_type":"regulatory","id":"b2bceefd-fdf7-4b32-8293-4d06534cf207","impact":"high","pub_date":"2026-05-05","source_url":"https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2026","summary":"The FDA approved Beqalzi (sonrotoclax) for relapsed or refractory mantle cell lymphoma in 2026."},{"ai_confidence":0.95,"created_at":"2026-05-14T02:32:02.626471","entity":"Unicycive Therapeutics","event_type":"regulatory","id":"42975166-f037-4846-9b33-fa42c4d7acc0","impact":"high","pub_date":"2026-05-05","source_url":"https://www.merlintradertradingpub.com/p/three-2026-fda-decisions-testing","summary":"Unicycive's OLC NDA resubmission is under FDA review, with a PDUFA target action date of June 29, 2026."},{"ai_confidence":0.9,"created_at":"2026-05-14T02:32:02.626463","entity":"Savara","event_type":"regulatory","id":"42d56dc1-a3bb-4701-99dc-b1f03b03613a","impact":"medium","pub_date":"2026-05-05","source_url":"https://www.merlintradertradingpub.com/p/three-2026-fda-decisions-testing","summary":"The FDA extended the review period for Savara's molgramostim BLA to November 22, 2026, without citing safety or efficacy concerns."},{"ai_confidence":0.8,"created_at":"2026-05-14T02:32:02.626455","entity":"FDA, AstraZeneca, Amgen","event_type":"regulatory","id":"c7ad921e-ebad-45e8-8972-aa0daf2afceb","impact":"low","pub_date":"2026-05-05","source_url":"https://www.europeanpharmaceuticalreview.com/news/184617/fda-marks-progress-in-implementing-real-time-clinical-trials/","summary":"The FDA is progressing real-time clinical trials (RTCTs), with AstraZeneca and Amgen commencing proof-of-concept RTCTs."},{"ai_confidence":0.85,"created_at":"2026-05-14T02:32:02.626447","entity":"Atea Pharmaceuticals","event_type":"product","id":"4ba9d429-3af1-4111-b3b2-9a14edffd3e8","impact":"medium","pub_date":"2026-05-05","source_url":"https://www.chemdiv.com/news/2026-clinical-trial-outlook-key-phase-3-reports-fda-filings-for-new-drugs","summary":"Atea Pharmaceuticals expects Phase 3 topline results for its Hepatitis C combination therapy mid-2026."},{"ai_confidence":0.85,"created_at":"2026-05-14T02:32:02.626439","entity":"Pfizer, Valneva","event_type":"product","id":"923493e2-2166-472b-97ae-b2bde424bf17","impact":"medium","pub_date":"2026-05-05","source_url":"https://www.chemdiv.com/news/2026-clinical-trial-outlook-key-phase-3-reports-fda-filings-for-new-drugs","summary":"Pfizer & Valneva's VLA15 vaccine candidate for Lyme Disease is in Phase 3, with data expected in 2026."},{"ai_confidence":0.95,"created_at":"2026-05-14T02:32:02.626431","entity":"MannKind Corporation","event_type":"regulatory","id":"65b32288-89a1-4362-a983-d90169d3dbd7","impact":"high","pub_date":"2026-05-05","source_url":"https://www.biopharmcatalyst.com/pdufa-calendar","summary":"MannKind Corporation's Afrezza\u00ae has a PDUFA approval decision date of May 29, 2026, for Type 1 and Type 2 diabetes."},{"ai_confidence":0.95,"created_at":"2026-05-14T02:32:02.626423","entity":"Astrazeneca","event_type":"regulatory","id":"9e3661c5-1429-4cea-b92f-e2dc34bcaaac","impact":"high","pub_date":"2026-05-05","source_url":"https://www.biopharmcatalyst.com/pdufa-calendar","summary":"Astrazeneca's Enhertu has a PDUFA approval decision date of May 18, 2026, for early-stage HER2+ breast cancer."},{"ai_confidence":0.95,"created_at":"2026-05-14T02:32:02.626415","entity":"Argenx","event_type":"regulatory","id":"8a5570f2-6997-4582-988b-aebc9f0701d1","impact":"high","pub_date":"2026-05-05","source_url":"https://www.biopharmcatalyst.com/pdufa-calendar","summary":"Argenx's VYVGART has a PDUFA approval decision date of May 10, 2026, for AChR-Ab seronegative Myasthenia gravis."},{"ai_confidence":0.9,"created_at":"2026-05-14T02:32:02.626406","entity":"Fosun, AriBio","event_type":"financial","id":"2ac4dc64-ce98-4c16-9a17-d2e2df9904e6","impact":"medium","pub_date":"2026-05-05","source_url":"https://www.fiercebiotech.com/","summary":"Fosun paid $60M for an option on AriBio's Phase 3 Alzheimer's asset."},{"ai_confidence":0.85,"created_at":"2026-05-14T02:32:02.626398","entity":"Kyverna","event_type":"regulatory","id":"798cf6f5-16fc-4d23-a6ee-d2c47024e02e","impact":"medium","pub_date":"2026-05-05","source_url":"https://www.fiercebiotech.com/","summary":"Kyverna began a rolling FDA submission for its autoimmune CAR-T therapy in SPS."},{"ai_confidence":0.95,"created_at":"2026-05-14T02:32:02.626389","entity":"Boehringer Ingelheim","event_type":"product","id":"922a67f3-16ae-430b-a7f7-c767f7d73877","impact":"high","pub_date":"2026-05-05","source_url":"https://www.drugs.com/clinical-trials.html","summary":"Boehringer Ingelheim's Survodutide achieved significant weight loss and metabolic improvement in positive topline results from the Phase 3 SYNCHRONIZE-1 trial."},{"ai_confidence":0.9,"created_at":"2026-05-14T02:32:02.626381","entity":"Eneboparatide","event_type":"product","id":"08a2227a-1af5-4eef-ae3d-3bcd131f7232","impact":"high","pub_date":"2026-05-05","source_url":"https://www.drugs.com/clinical-trials.html","summary":"Eneboparatide normalized serum calcium and achieved independence from supplements in 31.1% of adults with hypoparathyroidism in the CALYPSO Phase 3 trial."},{"ai_confidence":0.95,"created_at":"2026-05-14T02:32:02.626371","entity":"Guselkumab","event_type":"product","id":"9b7c5d33-0f00-4df8-8064-94e5b54ea1f4","impact":"high","pub_date":"2026-05-05","source_url":"https://www.appliedclinicaltrialsonline.com/view/guselkumab-phase-3-data-show-higher-fistula-remission-in-perianal-crohn-disease","summary":"Guselkumab (Tremfya) showed higher 24-week fistula remission than placebo in adults with perianal fistulizing Crohn disease in a Phase 3 trial."},{"ai_confidence":0.85,"created_at":"2026-05-14T02:32:02.626362","entity":"Aspenova","event_type":"product","id":"4faff13a-2c81-4189-a9ce-3ad94c7394fa","impact":"medium","pub_date":"2026-05-05","source_url":"https://www.appliedclinicaltrialsonline.com/view/first-patient-dosed-with-azenosertib-in-aspenova-phase-iii-trial-for-treatment-of-ovarian-cancer","summary":"The first patient was dosed with Azenosertib in the Phase 3 Aspenova trial for Cyclin E1-positive platinum-resistant ovarian cancer."},{"ai_confidence":0.95,"created_at":"2026-05-14T02:32:02.626352","entity":"Incyte","event_type":"product","id":"25fda582-a99c-40a1-9213-3f7cd4f6909f","impact":"high","pub_date":"2026-05-05","source_url":"https://www.appliedclinicaltrialsonline.com/view/incyte-announces-week-24-results-from-true-ad4-phase-iii-trial-of-opzelura","summary":"Incyte announced sustained 24-week efficacy and consistent safety data for Opzelura cream in moderate atopic dermatitis from its Phase 3 TRuE-AD4 trial."},{"ai_confidence":0.8,"created_at":"2026-05-14T02:32:02.626341","entity":"FDA, TransCelerate","event_type":"regulatory","id":"239f2e00-e548-4377-9300-34bd03874bb9","impact":"low","pub_date":"2026-05-05","source_url":"https://www.appliedclinicaltrialsonline.com/view/transcelerate-and-fda-advance-work-on-streamlined-safety-data-collection-for-pragmatic-clinical-trials","summary":"TransCelerate and the FDA are advancing work on streamlined safety data collection for pragmatic clinical trials."},{"ai_confidence":0.95,"created_at":"2026-05-14T02:32:02.626320","entity":"Moderna","event_type":"product","id":"28ad3eac-0747-40c4-b20d-1c9842e1b3d3","impact":"high","pub_date":"2026-05-05","source_url":"https://www.appliedclinicaltrialsonline.com/view/phase-3-trial-finds-moderna-s-mrna-1010-influenza-vaccine-outperformed-standard-dose-vaccines-in-adults-aged-50-years-and-older","summary":"Moderna's mRNA-1010 influenza vaccine outperformed standard-dose vaccines in a global Phase 3 study for adults aged 50+."},{"ai_confidence":0.85,"created_at":"2026-05-14T02:32:02.625688","entity":"Intellia Therapeutics","event_type":"regulatory","id":"16daf785-971d-4dd2-a488-12b2d319ffef","impact":"medium","pub_date":"2026-05-05","source_url":"https://www.biospace.com/article/phase-iii-clinical-trials/","summary":"Intellia Therapeutics is seeking FDA approval for its in vivo CRISPR gene editing therapy for hereditary angioedema, with Phase 3 data."},{"ai_confidence":0.85,"created_at":"2026-05-14T02:32:02.625681","entity":"Novo Nordisk","event_type":"regulatory","id":"f7b747e5-179e-4c8e-951d-adf6a2a63b97","impact":"medium","pub_date":"2026-05-05","source_url":"https://www.biospace.com/article/phase-iii-clinical-trials/","summary":"Novo Nordisk plans to seek FDA approval for etavopivat in the latter half of 2026."},{"ai_confidence":0.9,"created_at":"2026-05-14T02:32:02.625674","entity":"Novo Nordisk","event_type":"product","id":"b9991795-9b6c-4656-95ff-05cf0d77302f","impact":"high","pub_date":"2026-05-05","source_url":"https://www.biospace.com/article/phase-iii-clinical-trials/","summary":"Novo Nordisk's etavopivat showed a 27% drop in vaso-occlusive crises and 48.7% hemoglobin response in a Phase 3 study."},{"ai_confidence":0.9,"created_at":"2026-05-14T02:32:02.625665","entity":"Viridian Therapeutics","event_type":"regulatory","id":"2b2251ec-5642-466f-91c8-927c12daaf72","impact":"medium","pub_date":"2026-05-05","source_url":"https://www.businesswire.com/news/home/20260505005289/en/Viridian-Therapeutics-Announces-Positive-Topline-Results-from-Elegrobart-Phase-3-REVEAL%E2%80%912-Clinical-Trial-in-Chronic-Thyroid-Eye-Disease","summary":"Viridian Therapeutics plans to submit a Biologics License Application (BLA) to the U.S. FDA for elegrobart in Q1 2027."},{"ai_confidence":0.95,"created_at":"2026-05-14T02:32:02.625644","entity":"Viridian Therapeutics","event_type":"product","id":"afed1fd0-c8a3-45dd-8d37-611155ee1d6f","impact":"high","pub_date":"2026-05-05","source_url":"https://www.businesswire.com/news/home/20260505005289/en/Viridian-Therapeutics-Announces-Positive-Topline-Results-from-Elegrobart-Phase-3-REVEAL%E2%80%912-Clinical-Trial-in-Chronic-Thyroid-Eye-Disease","summary":"Viridian Therapeutics announced positive topline results from its Phase 3 REVEAL-2 clinical trial for elegrobart in chronic thyroid eye disease."},{"ai_confidence":0.8,"created_at":"2026-05-13T02:15:39.877112","entity":"Amgen","event_type":"product","id":"cf3597f1-9e97-4826-aeab-5389aec14c3d","impact":"low","pub_date":"2026-05-01","source_url":"https://www.europeanpharmaceuticalreview.com/fda-marks-progress-in-implementing-real-time-clinical-trials/2135372.article","summary":"Amgen initiated a Phase Ib real-time clinical trial (STREAM-SCLC) for small cell lung carcinoma, reporting data to the FDA."},{"ai_confidence":0.8,"created_at":"2026-05-13T02:15:39.877105","entity":"AstraZeneca","event_type":"product","id":"912c0d33-9450-481f-bf28-a68e91630eb3","impact":"low","pub_date":"2026-05-01","source_url":"https://www.europeanpharmaceuticalreview.com/fda-marks-progress-in-implementing-real-time-clinical-trials/2135372.article","summary":"AstraZeneca initiated a Phase II real-time clinical trial (TRAVERSE) for mantle cell lymphoma, reporting data to the FDA."},{"ai_confidence":0.8,"created_at":"2026-05-13T02:15:39.877098","entity":"FDA","event_type":"regulatory","id":"00bb80d9-6675-44ae-8540-6d0039e28a6e","impact":"low","pub_date":"2026-05-01","source_url":"https://www.europeanpharmaceuticalreview.com/fda-marks-progress-in-implementing-real-time-clinical-trials/2135372.article","summary":"The FDA is making progress in implementing real-time clinical trials (RTCTs) to modernize the drug development process."},{"ai_confidence":0.7,"created_at":"2026-05-13T02:15:39.877090","entity":"Eneboparatide","event_type":"product","id":"eff42a4f-1a3b-4320-addc-498a6da1cf1a","impact":"medium","pub_date":"2026-05-01","source_url":"https://www.drugs.com/clinical_trials.html","summary":"Positive results from the CALYPSO Phase III trial showed eneboparatide normalized serum calcium in adults with hypoparathyroidism."},{"ai_confidence":0.9,"created_at":"2026-05-13T02:15:39.877082","entity":"Coya Therapeutics","event_type":"regulatory","id":"df6365de-d49f-4bba-bdbc-66ca8b4279bf","impact":"medium","pub_date":"2026-05-01","source_url":"https://www.drugs.com/clinical_trials.html","summary":"Coya Therapeutics received U.S. FDA Fast Track Designation for COYA 302 for the treatment of Amyotrophic Lateral Sclerosis (ALS)."},{"ai_confidence":0.8,"created_at":"2026-05-13T02:15:39.877075","entity":"Viridian Therapeutics","event_type":"product","id":"a5c3cf14-f6d6-4c5f-ab41-40009272b82f","impact":"medium","pub_date":"2026-05-01","source_url":"https://www.drugs.com/clinical_trials.html","summary":"Viridian Therapeutics announced positive topline results from the Elegrobart Phase 3 REVEAL\u20112 clinical trial for chronic thyroid eye disease."},{"ai_confidence":0.7,"created_at":"2026-05-13T02:15:39.877067","entity":"Guselkumab (Tremfya)","event_type":"product","id":"2485312e-4409-45f9-b253-355e407a10fe","impact":"medium","pub_date":"2026-05-01","source_url":"https://www.appliedclinicaltrialsonline.com/news","summary":"Guselkumab (Tremfya) showed higher 24-week fistula remission than placebo in adults with perianal fistulizing Crohn's disease in Phase 3 data."},{"ai_confidence":0.8,"created_at":"2026-05-13T02:15:39.877053","entity":"Incyte","event_type":"product","id":"119e9da9-32d8-49b5-b6cd-774452af7b73","impact":"medium","pub_date":"2026-05-01","source_url":"https://www.appliedclinicaltrialsonline.com/news","summary":"Incyte reported positive 24-week efficacy and consistent safety data for Opzelura cream in moderate atopic dermatitis from its Phase III trial."},{"ai_confidence":0.8,"created_at":"2026-05-13T02:15:39.877046","entity":"Moderna","event_type":"product","id":"017e043a-973a-486b-9029-7932d38ad4fc","impact":"medium","pub_date":"2026-05-01","source_url":"https://www.appliedclinicaltrialsonline.com/news","summary":"Moderna's mRNA-1010 influenza vaccine demonstrated superior performance against standard-dose vaccines in a global Phase 3 study."},{"ai_confidence":0.9,"created_at":"2026-05-13T02:15:39.877037","entity":"FDA","event_type":"regulatory","id":"fbc5d1a6-3275-4ead-8435-5f9ea4f45f35","impact":"medium","pub_date":"2026-05-01","source_url":"https://www.appliedclinicaltrialsonline.com/view/fda-real-time-clinical-trials","summary":"The FDA launched proof-of-concept real-time clinical trials and issued an RFI to explore expanding this continuous development model."},{"ai_confidence":1.0,"created_at":"2026-05-13T02:15:39.877018","entity":"Argenx","event_type":"regulatory","id":"7a408289-8faf-49d2-9ace-43090ccac387","impact":"high","pub_date":"2026-05-08","source_url":"https://www.globenewswire.com/news-release/2026/05/08/3291372/0/en/argenx-announces-u-s-fda-approval-expanding-vyvgart-and-vyvgart-hytrulo-for-use-in-all-adult-patients-living-with-gmg.html","summary":"Argenx received FDA approval to expand VYVGART's indication for all adult patients with generalized myasthenia gravis (gMG)."},{"ai_confidence":0.9,"created_at":"2026-05-12T02:03:03.552118","entity":"Saphnelo","event_type":"regulatory","id":"aa2d56c5-d563-48b8-893a-bbaa11c94b31","impact":"medium","pub_date":"2026-01-01","source_url":"https://www.goodrx.com/healthcare-access/research/fda-approvals-2026","summary":"FDA is considering Saphnelo (anifrolumab) as a subcutaneous injection for lupus."},{"ai_confidence":0.92,"created_at":"2026-05-12T02:03:03.552109","entity":"Ensitrelvir","event_type":"regulatory","id":"fcc7d595-43d8-4f6f-8619-b009d7bfc8ae","impact":"medium","pub_date":"2026-01-01","source_url":"https://www.goodrx.com/healthcare-access/research/fda-approvals-2026","summary":"Ensitrelvir is under FDA review for COVID-19 prevention, with a decision expected by June 16, 2026."},{"ai_confidence":0.9,"created_at":"2026-05-12T02:03:03.552101","entity":"Afrezza","event_type":"regulatory","id":"a4f0c59c-eb9b-4194-9db2-02fd1eee7f12","impact":"medium","pub_date":"2026-01-01","source_url":"https://www.goodrx.com/healthcare-access/research/fda-approvals-2026","summary":"Afrezza (inhaled insulin) is anticipated for potential FDA approval in 2026 for children with diabetes."},{"ai_confidence":0.9,"created_at":"2026-05-12T02:03:03.552093","entity":"Wegovy","event_type":"regulatory","id":"d721ebeb-67fb-46a9-bd99-299458dbac16","impact":"medium","pub_date":"2026-01-01","source_url":"https://www.goodrx.com/healthcare-access/research/fda-approvals-2026","summary":"Wegovy (semaglutide) is anticipated for potential FDA approval in 2026 for heart failure with preserved ejection fraction."},{"ai_confidence":0.9,"created_at":"2026-05-12T02:03:03.552084","entity":"Amgen","event_type":"product","id":"03af4ed7-3252-4009-af8e-c0cda8c0ee97","impact":"low","pub_date":"2026-05-01","source_url":"https://www.raps.org/news-and-articles/news-articles/2026/5/fda-marks-progress-in-implementing-real-time-clinical-trials","summary":"Amgen initiated a Phase Ib real-time clinical trial (STREAM-SCLC) for small cell lung carcinoma."},{"ai_confidence":0.9,"created_at":"2026-05-12T02:03:03.552075","entity":"AstraZeneca","event_type":"product","id":"2c418413-5369-4739-94c8-737e6dbee99d","impact":"low","pub_date":"2026-05-01","source_url":"https://www.raps.org/news-and-articles/news-articles/2026/5/fda-marks-progress-in-implementing-real-time-clinical-trials","summary":"AstraZeneca initiated a Phase II real-time clinical trial (TRAVERSE) for mantle cell lymphoma."},{"ai_confidence":0.95,"created_at":"2026-05-12T02:03:03.552067","entity":"FDA","event_type":"regulatory","id":"f0577cf6-c9ef-4987-9f68-4a54929d0637","impact":"medium","pub_date":"2026-05-01","source_url":"https://www.raps.org/news-and-articles/news-articles/2026/5/fda-marks-progress-in-implementing-real-time-clinical-trials","summary":"FDA is advancing real-time clinical trials (RTCTs) to accelerate therapies, with AstraZeneca and Amgen initiating studies."},{"ai_confidence":0.98,"created_at":"2026-05-12T02:03:03.552058","entity":"Lifyorli","event_type":"regulatory","id":"250854ca-b830-4d7c-b6a1-dd78271f0de3","impact":"high","pub_date":"2026-01-01","source_url":"https://www.fda.gov/drugs/drug-approvals-and-databases/novel-drug-approvals-2026","summary":"FDA approved Lifyorli (relacorilant) for certain ovarian cancers in 2026."},{"ai_confidence":0.98,"created_at":"2026-05-12T02:03:03.552049","entity":"Awiqli","event_type":"regulatory","id":"7aa8043a-09f5-4004-8f89-6d0f503d0ed0","impact":"high","pub_date":"2026-01-01","source_url":"https://www.fda.gov/drugs/drug-approvals-and-databases/novel-drug-approvals-2026","summary":"FDA approved Awiqli (insulin icodec-abae) for type 2 diabetes in 2026."},{"ai_confidence":0.98,"created_at":"2026-05-12T02:03:03.552041","entity":"Foundayo","event_type":"regulatory","id":"a10e47cd-d2ba-4cd5-953f-0b63c8fcbed7","impact":"high","pub_date":"2026-01-01","source_url":"https://www.fda.gov/drugs/drug-approvals-and-databases/novel-drug-approvals-2026","summary":"FDA approved Foundayo (orforglipron) for weight management in 2026."},{"ai_confidence":0.98,"created_at":"2026-05-12T02:03:03.552032","entity":"Idvynso","event_type":"regulatory","id":"b5a40b57-a87d-4482-b106-c0e9de44f240","impact":"high","pub_date":"2026-01-01","source_url":"https://www.fda.gov/drugs/drug-approvals-and-databases/novel-drug-approvals-2026","summary":"FDA approved Idvynso (doravirine and islatravir) for HIV-1 in 2026."},{"ai_confidence":0.98,"created_at":"2026-05-12T02:03:03.552024","entity":"Veppanu","event_type":"regulatory","id":"d898a1d5-696d-428f-8ff5-de9ee3033d38","impact":"high","pub_date":"2026-01-01","source_url":"https://www.fda.gov/drugs/drug-approvals-and-databases/novel-drug-approvals-2026","summary":"FDA approved Veppanu (vepdegestrant) for certain types of breast cancer in 2026."},{"ai_confidence":0.92,"created_at":"2026-05-12T02:03:03.552015","entity":"Intellia Therapeutics","event_type":"regulatory","id":"210945b9-407c-4644-baa9-b42849e84555","impact":"medium","pub_date":"2026-01-01","source_url":"https://www.biospace.com/article/tags/phase-iii-clinical-trials/","summary":"Intellia Therapeutics is seeking FDA approval for its in vivo CRISPR gene editing therapy for hereditary angioedema."},{"ai_confidence":0.95,"created_at":"2026-05-12T02:03:03.552006","entity":"Summit 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planned."},{"ai_confidence":0.98,"created_at":"2026-05-12T02:03:03.551971","entity":"AstraZeneca","event_type":"regulatory","id":"63c12b0a-ed26-46ee-b6fc-4f6535de65b5","impact":"high","pub_date":"2026-01-01","source_url":"https://www.marketbeat.com/stocks/NASDAQ/AZN/fda-approvals/","summary":"FDA approved AstraZeneca's IMFINZI (durvalumab) for limited-stage small cell lung cancer based on ADRIATIC Phase III data."},{"ai_confidence":0.95,"created_at":"2026-05-12T02:03:03.551336","entity":"AstraZeneca","event_type":"product","id":"4fea188b-28e1-46ca-8afc-30c83e812fc9","impact":"high","pub_date":"2026-01-01","source_url":"https://www.marketbeat.com/stocks/NASDAQ/AZN/fda-approvals/","summary":"AstraZeneca's IMFINZI (durvalumab) showed positive Phase III MATTERHORN trial results, improving event-free survival."},{"ai_confidence":1.0,"created_at":"2026-05-11T01:47:42.438699","entity":"Viridian 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results."},{"ai_confidence":1.0,"created_at":"2026-05-11T01:47:42.438684","entity":"Viridian Therapeutics","event_type":"product","id":"680b8d1a-ff36-473e-9cd0-39abd67ef3c8","impact":"high","pub_date":"2024-06-10","source_url":"https://www.drugs.com/clinical_trials/viridian-therapeutics-announces-positive-topline-results-elegrobart-phase-3-reveal-2-clinical-trial-22426.html","summary":"Viridian Therapeutics announced positive topline results for Elegrobart Phase 3 REVEAL-2 trial in chronic TED, meeting its primary endpoint."},{"ai_confidence":1.0,"created_at":"2026-05-11T01:47:42.438676","entity":"Vera Therapeutics, Inc.","event_type":"regulatory","id":"575a85be-391a-4dd0-bf96-48ca62af819d","impact":"high","pub_date":"2024-06-10","source_url":"https://www.stocktitan.net/sec-filings/VERA/8-k-vera-therapeutics-inc-reports-material-event-bc58219ec190.html","summary":"The FDA granted Priority Review to Vera Therapeutics' atacicept BLA for IgAN treatment, setting a PDUFA date of July 7, 2026."},{"ai_confidence":1.0,"created_at":"2026-05-11T01:47:42.438662","entity":"Vera Therapeutics, Inc.","event_type":"product","id":"c904967a-2160-4b05-8813-1fb02828d9ac","impact":"high","pub_date":"2024-06-10","source_url":"https://www.stocktitan.net/sec-filings/VERA/8-k-vera-therapeutics-inc-reports-material-event-bc58219ec190.html","summary":"Vera Therapeutics' atacicept Phase 3 trial met its primary endpoint for IgAN, showing significant proteinuria reduction and a favorable safety profile."},{"ai_confidence":0.85,"created_at":"2026-05-10T01:31:54.728012","entity":"AstraZeneca","event_type":"product","id":"55c68bb5-2ffc-42f0-a38d-92a9c405f95d","impact":"low","pub_date":"2024-05-20","source_url":"https://www.techtarget.com/pharmalifesciences/news/366642589/FDA-moves-toward-real-time-review-of-clinical-trial-data","summary":"The FDA received and validated signals from AstraZeneca's mid-stage clinical trial as part of its real-time data review initiative."},{"ai_confidence":0.9,"created_at":"2026-05-10T01:31:54.728006","entity":"AstraZeneca, Amgen, Paradigm Health","event_type":"partnership","id":"45af6ef7-ebca-48bd-8bfa-455925f89728","impact":"medium","pub_date":"2024-05-20","source_url":"https://www.techtarget.com/pharmalifesciences/news/366642589/FDA-moves-toward-real-time-review-of-clinical-trial-data","summary":"AstraZeneca and Amgen are running proof-of-concept cancer studies with Paradigm Health platforms for FDA's real-time data review."},{"ai_confidence":0.95,"created_at":"2026-05-10T01:31:54.727999","entity":"FDA","event_type":"regulatory","id":"c19d7134-3e6f-4af8-8641-d058eb0bbdf8","impact":"high","pub_date":"2024-05-20","source_url":"https://www.techtarget.com/pharmalifesciences/news/366642589/FDA-moves-toward-real-time-review-of-clinical-trial-data","summary":"The FDA is moving towards real-time review of clinical trial data using AI and cloud computing to accelerate drug development."},{"ai_confidence":0.8,"created_at":"2026-05-10T01:31:54.727992","entity":"","event_type":"product","id":"1450566b-b070-47b9-83d1-8ac1aadec0b1","impact":"medium","pub_date":"2024-05-20","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":0.8,"created_at":"2026-05-10T01:31:54.727984","entity":"","event_type":"product","id":"f7a2191d-cf67-4c5f-ab58-a384fd3a8dd5","impact":"medium","pub_date":"2024-05-20","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":0.85,"created_at":"2026-05-10T01:31:54.727977","entity":"Novo Nordisk","event_type":"product","id":"28a58e73-7a3f-478f-9ac9-5480fb6052ff","impact":"medium","pub_date":"2024-05-20","source_url":"https://www.goodrx.com/drugs/news/upcoming-fda-approvals","summary":"Ozempic (Novo Nordisk) is anticipated to potentially receive FDA approval for peripheral artery disease in 2026."},{"ai_confidence":0.9,"created_at":"2026-05-10T01:31:54.727970","entity":"Merck","event_type":"product","id":"ae4f8e58-503f-4d6f-af7d-1268b72fdf0a","impact":"medium","pub_date":"2024-05-20","source_url":"https://www.pharmavoice.com/news/fda-drug-approval-takeda-novo-merck-lilly-2026/808924/","summary":"Merck presented positive Phase 3 trial results for enlicitide, showing significant LDL cholesterol reduction with a favorable safety profile."},{"ai_confidence":0.9,"created_at":"2026-05-10T01:31:54.727963","entity":"Regenxbio","event_type":"regulatory","id":"bed2fc54-9742-49ee-8c1a-f452728e434e","impact":"medium","pub_date":"2024-05-20","source_url":"https://www.pharmavoice.com/news/fda-drug-approval-takeda-novo-merck-lilly-2026/808924/","summary":"Regenxbio's gene therapy RGX-121 for Hunter syndrome has a PDUFA goal date of February 8, 2026, for potential FDA approval."},{"ai_confidence":0.9,"created_at":"2026-05-10T01:31:54.727956","entity":"Atea Pharmaceuticals","event_type":"product","id":"0d96e160-e512-4362-af3d-31132b10772b","impact":"medium","pub_date":"2024-05-20","source_url":"https://www.chemdiv.com/company/media/pharma-news/2026/phase3-clinical-trials-2026-fda-approvals-lyme-hcv-crab-hiv/","summary":"Atea Pharmaceuticals expects Phase 3 topline results for bemnifosbuvir and ruzasvir for Hepatitis C in mid-2026."},{"ai_confidence":0.9,"created_at":"2026-05-10T01:31:54.727947","entity":"Pfizer, Valneva","event_type":"product","id":"5b681efa-d1ae-4209-b37d-158bb9bb640c","impact":"medium","pub_date":"2024-05-20","source_url":"https://www.chemdiv.com/company/media/pharma-news/2026/phase3-clinical-trials-2026-fda-approvals-lyme-hcv-crab-hiv/","summary":"Pfizer and Valneva completed primary observation for their Lyme disease vaccine candidate VLA15, with data expected in 2026."},{"ai_confidence":0.95,"created_at":"2026-05-10T01:31:54.727938","entity":"FDA","event_type":"regulatory","id":"f4208b2c-d0e3-4c17-bd7b-43f2cfe9a1d8","impact":"high","pub_date":"2024-05-20","source_url":"https://www.propharmagroup.com/thought-leadership/fda-default-drug-approval-requirements-one-pivotal-trial-regulatory-strategy-implications","summary":"The FDA formally confirmed that a single pivotal trial can support drug approval, increasing scrutiny on trial design and data handling."},{"ai_confidence":0.95,"created_at":"2026-05-10T01:31:54.727923","entity":"FDA","event_type":"regulatory","id":"2e4db67f-1752-4f49-8190-e3820f2243e3","impact":"high","pub_date":"2024-05-20","source_url":"https://www.pharmaceuticalcommerce.com/view/fda-shifts-toward-single-trial-requirement-new-drug-approvals","summary":"The FDA is shifting its policy to emphasize a single adequate, well-controlled trial for drug approvals, potentially shortening development timelines."},{"ai_confidence":0.9,"created_at":"2026-05-09T01:16:52.380972","entity":"Abbvie","event_type":"regulatory","id":"e8395ef9-8591-44c1-aa71-f9a5c9a15790","impact":"medium","pub_date":"2024-05-01","source_url":"https://www.primetherapeutics.com/news/fda-decisions-expected-april-2026/","summary":"Abbvie submitted an NDA for PVEK, a CD123-targeting antibody-drug conjugate for BPDCN, which received Breakthrough Therapy designation."},{"ai_confidence":0.8,"created_at":"2026-05-09T01:16:52.380965","entity":"FDA","event_type":"regulatory","id":"0b2f9405-84e5-4b85-a00b-5d45fb6bdb2a","impact":"low","pub_date":"2024-05-01","source_url":"https://www.fda.gov/about-fda/reports-congress/fda-track-prescription-drug-user-fee-act-pdufa-performance-dashboards","summary":"The FDA updated its PDUFA Performance Dashboards, providing visual data on PDUFA goal performance for FY 2024-2026."},{"ai_confidence":0.9,"created_at":"2026-05-09T01:16:52.380958","entity":"Vera Therapeutics Inc., Elevar Therapeutics Inc., Mannkind Corp.","event_type":"regulatory","id":"a5d465c6-460d-455a-bcf9-3a4664775298","impact":"medium","pub_date":"2024-05-01","source_url":"https://www.bioworld.com/articles/700089-pduda-drugs-on-deck-fda-approval-action-dates","summary":"Several companies, including Vera Therapeutics, Elevar Therapeutics, and Mannkind, have upcoming PDUFA dates for potential FDA approval decisions."},{"ai_confidence":0.85,"created_at":"2026-05-09T01:16:52.380952","entity":"Roche","event_type":"product","id":"9600e5d4-8b34-4fd7-9df3-07f867e0849d","impact":"low","pub_date":"2024-05-01","source_url":"https://chemdiv.com/news/2026-clinical-trial-outlook-key-phase-3-reports-fda-filings-for-new-drugs/","summary":"Roche plans to initiate a Phase 3 trial for zosurabalpin, a novel antibiotic candidate targeting CRAB infections."},{"ai_confidence":0.9,"created_at":"2026-05-09T01:16:52.380945","entity":"Atea Pharmaceuticals","event_type":"product","id":"999e3f9f-7e54-4663-9c20-80cd4fa015b9","impact":"medium","pub_date":"2024-05-01","source_url":"https://chemdiv.com/news/2026-clinical-trial-outlook-key-phase-3-reports-fda-filings-for-new-drugs/","summary":"Atea Pharmaceuticals expects topline Phase 3 results for its bemnifosbuvir + ruzasvir combination for Hepatitis C in mid-2026."},{"ai_confidence":0.9,"created_at":"2026-05-09T01:16:52.380939","entity":"Pfizer, Valneva","event_type":"product","id":"ff911664-9c41-405c-a066-27e221001cf0","impact":"medium","pub_date":"2024-05-01","source_url":"https://chemdiv.com/news/2026-clinical-trial-outlook-key-phase-3-reports-fda-filings-for-new-drugs/","summary":"Pfizer and Valneva's VLA15 Lyme disease vaccine candidate is in Phase 3, with data expected in 2026."},{"ai_confidence":0.9,"created_at":"2026-05-09T01:16:52.380932","entity":"Amgen","event_type":"regulatory","id":"40df8f50-6457-4512-b38d-33cf5ce83a18","impact":"medium","pub_date":"2026-04-29","source_url":"https://www.fiercebiotech.com/regulatory/fda-unveils-plan-real-time-review-clinical-trial-data-astrazeneca-and-amgen-already-board","summary":"Amgen is participating in the FDA's pilot program for real-time clinical trial data review, focusing on a trial for limited-stage small cell lung carcinoma."},{"ai_confidence":0.9,"created_at":"2026-05-09T01:16:52.380924","entity":"AstraZeneca","event_type":"regulatory","id":"03654504-67a8-49f4-8db1-bf25215f5f37","impact":"medium","pub_date":"2026-04-29","source_url":"https://www.fiercebiotech.com/regulatory/fda-unveils-plan-real-time-review-clinical-trial-data-astrazeneca-and-amgen-already-board","summary":"AstraZeneca is participating in the FDA's pilot program for real-time clinical trial data review, involving trials for Calquence, Venclexta, and rituximab."},{"ai_confidence":0.95,"created_at":"2026-05-09T01:16:52.380905","entity":"FDA","event_type":"regulatory","id":"6de26a35-6975-4964-a332-2df8c6979a05","impact":"high","pub_date":"2026-04-29","source_url":"https://www.fiercebiotech.com/regulatory/fda-unveils-plan-real-time-review-clinical-trial-data-astrazeneca-and-amgen-already-board","summary":"The FDA unveiled a new initiative for real-time access to clinical trial data, with AstraZeneca and Amgen participating in a pilot program."},{"ai_confidence":0.9,"created_at":"2026-05-09T01:16:52.380897","entity":"AstraZeneca","event_type":"regulatory","id":"dfc94644-2985-49e8-b928-8f61fc530ece","impact":"medium","pub_date":"2024-05-01","source_url":"https://www.goodrx.com/healthcare-access/research/fda-approvals","summary":"A subcutaneous version of AstraZeneca's Saphnelo for SLE is under FDA review, with a decision expected in the first half of 2026."},{"ai_confidence":0.9,"created_at":"2026-05-09T01:16:52.380888","entity":"Unknown","event_type":"regulatory","id":"02487486-e75a-4321-9e78-b626889f8b5c","impact":"medium","pub_date":"2024-05-01","source_url":"https://www.goodrx.com/healthcare-access/research/fda-approvals","summary":"Anaphylm, a sublingual epinephrine film, is under FDA review, with its manufacturer planning to refile as early as Q3 2026."},{"ai_confidence":0.9,"created_at":"2026-05-09T01:16:52.380881","entity":"Unknown","event_type":"regulatory","id":"0fd9dda2-a337-4927-8a33-e71af18d5373","impact":"medium","pub_date":"2024-05-01","source_url":"https://www.goodrx.com/healthcare-access/research/fda-approvals","summary":"The FDA is expected to make a decision on Cytisinicline, a potential smoking cessation medication, by June 20, 2026."},{"ai_confidence":0.9,"created_at":"2026-05-09T01:16:52.380874","entity":"Viridian Therapeutics","event_type":"product","id":"240447ca-5225-4d99-8be5-1d2322c308a0","impact":"medium","pub_date":"2024-05-01","source_url":"https://www.biospace.com/article/topics/clinical-trials/?keywords=Phase%20III","summary":"Viridian Therapeutics' elegrobart normalized eye protrusion and improved double vision in a Phase 3 study, with FDA filing planned for Q1 2027."},{"ai_confidence":0.9,"created_at":"2026-05-09T01:16:52.380866","entity":"Revolution Medicines","event_type":"product","id":"14819810-449e-43d9-9500-5d3b124f600e","impact":"medium","pub_date":"2024-05-01","source_url":"https://www.biospace.com/article/topics/clinical-trials/?keywords=Phase%20III","summary":"Revolution Medicines reported significant survival improvement in a pancreatic cancer Phase 3 trial, supporting global regulatory filings."},{"ai_confidence":0.9,"created_at":"2026-05-09T01:16:52.380853","entity":"Novo Nordisk","event_type":"product","id":"49c751fd-8a93-4621-b9e7-f40cbaecc13a","impact":"medium","pub_date":"2024-05-01","source_url":"https://www.biospace.com/article/topics/clinical-trials/?keywords=Phase%20III","summary":"Novo Nordisk's etavopivat showed positive Phase 3 results for vaso-occlusive crises and hemoglobin response, with FDA approval planned for H2 2026."},{"ai_confidence":0.9,"created_at":"2026-05-08T01:01:49.379148","entity":"Viridian Therapeutics","event_type":"product","id":"06b5bf5e-09de-4fb6-bcfc-3324f5ec9043","impact":"high","pub_date":"2026-05-01","source_url":"https://investors.viridiantherapeutics.com/news/news-details/2026/Viridian-Therapeutics-Announces-Positive-Topline-Results-from-Elegrobart-Phase-3-REVEAL2-Clinical-Trial-in-Chronic-Thyroid-Eye-Disease/default.aspx","summary":"Viridian Therapeutics announced positive topline Phase 3 results from the REVEAL-2 trial for Elegrobart in chronic thyroid eye disease."},{"ai_confidence":1.0,"created_at":"2026-05-08T01:01:49.379139","entity":"Celcuity","event_type":"regulatory","id":"93b48072-128a-4b4c-9dc1-a0fed9d8d402","impact":"medium","pub_date":"2026-05-01","source_url":"https://www.stocktitan.net/news/CELC/celcuity-celc-posts-positive-phase-3-gedatolisib-data-eyes-fda-snda-and-july-2026-pdufa-2026-05-01-20-38-349964.html","summary":"Celcuity's existing NDA for gedatolisib in PIK3CA wild-type disease is under FDA Priority Review with a PDUFA date of July 17, 2026."},{"ai_confidence":1.0,"created_at":"2026-05-08T01:01:49.379130","entity":"Celcuity","event_type":"regulatory","id":"fc012749-ab49-4ade-a3cc-a9a47ec82f7e","impact":"medium","pub_date":"2026-05-01","source_url":"https://www.stocktitan.net/news/CELC/celcuity-celc-posts-positive-phase-3-gedatolisib-data-eyes-fda-snda-and-july-2026-pdufa-2026-05-01-20-38-349964.html","summary":"Celcuity plans to submit a supplemental New Drug Application (sNDA) to the FDA for gedatolisib based on positive Phase 3 data."},{"ai_confidence":1.0,"created_at":"2026-05-08T01:01:49.379114","entity":"Celcuity","event_type":"product","id":"b968f27f-72a6-4139-9a36-97ead48cdf5d","impact":"high","pub_date":"2026-05-01","source_url":"https://www.stocktitan.net/news/CELC/celcuity-celc-posts-positive-phase-3-gedatolisib-data-eyes-fda-snda-and-july-2026-pdufa-2026-05-01-20-38-349964.html","summary":"Celcuity announced positive topline Phase 3 results for gedatolisib in the VIKTORIA-1 trial for PIK3CA mutant HR+/HER2- advanced breast cancer."},{"ai_confidence":0.95,"created_at":"2026-05-07T00:46:56.380714","entity":"FDA","event_type":"regulatory","id":"61099360-235c-4a09-abba-1f7ba93bbcf9","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, never before marketed in the U.S., during the year 2025."},{"ai_confidence":0.8,"created_at":"2026-05-07T00:46:56.380703","entity":"FDA / Multiple companies","event_type":"regulatory","id":"6a607282-063f-4936-9838-f09e26e430ff","impact":"high","pub_date":"2026-01-01","source_url":"https://www.goodrx.com/drugs/news/upcoming-fda-approvals?srsltid=AfmBOoqcUwFfx-Puv5M50-GhBXPm3yDd2RGHO5EhYsCA_jdJjeiLJJKD","summary":"Multiple novel drugs and new uses for existing medications are anticipated to receive FDA approval in 2026."},{"ai_confidence":0.85,"created_at":"2026-05-07T00:46:56.380674","entity":"Ionis Pharmaceuticals, Inc.","event_type":"product","id":"73840aad-50b5-4b34-b2cc-dfdaeadd60c1","impact":"medium","pub_date":"2024-07-01","source_url":"https://www.fdatracker.com/2024/07/phase-3-clinical-trials-with-primary-completion-dates-in-july-2024/","summary":"Ionis Pharmaceuticals' Phase 3 trial completed its primary data collection in July 2024."},{"ai_confidence":0.9,"created_at":"2026-05-07T00:46:56.379725","entity":"Equillium, Inc.","event_type":"product","id":"929a293d-2684-4560-9ae7-ce707bcd9820","impact":"medium","pub_date":"2024-07-01","source_url":"https://www.fdatracker.com/2024/07/phase-3-clinical-trials-with-primary-completion-dates-in-july-2024/","summary":"Equillium's Phase 3 EQUATOR study of itolizumab for acute GVHD completed primary data collection in July 2024."},{"ai_confidence":0.85,"created_at":"2026-05-07T00:46:56.379715","entity":"Agios Pharmaceuticals, Inc.","event_type":"product","id":"d5b83c42-89c4-4cc9-bf3a-8438e0c590e5","impact":"medium","pub_date":"2024-06-01","source_url":"https://www.fdatracker.com/2024/06/phase-3-clinical-trials-with-primary-completion-dates-in-june-2024/","summary":"Agios Pharmaceuticals' Phase 3 trial completed its primary data collection in June 2024."},{"ai_confidence":0.9,"created_at":"2026-05-07T00:46:56.379707","entity":"Aeterna Zentaris Inc.","event_type":"product","id":"4e3377f2-ccd9-449f-8296-f30a0b45ae72","impact":"medium","pub_date":"2024-06-01","source_url":"https://www.fdatracker.com/2024/06/phase-3-clinical-trials-with-primary-completion-dates-in-june-2024/","summary":"Aeterna Zentaris' Phase 3 trial for macimorelin in growth hormone deficiency completed primary data collection in June 2024."},{"ai_confidence":0.85,"created_at":"2026-05-07T00:46:56.379698","entity":"Atea Pharmaceuticals, Inc.","event_type":"product","id":"f7c57f4a-773c-477a-a0e0-cfde9443e1de","impact":"medium","pub_date":"2024-03-01","source_url":"https://www.fdatracker.com/2024/03/phase-3-clinical-trials-with-primary-completion-dates-in-march-2024/","summary":"Atea Pharmaceuticals' Phase 3 trial (NCT05629962) completed its primary data collection in March 2024."},{"ai_confidence":0.9,"created_at":"2026-05-07T00:46:56.379688","entity":"ACADIA Pharmaceuticals Inc.","event_type":"product","id":"ae57cb15-07ed-4f0e-bcf3-091c1ce62b25","impact":"medium","pub_date":"2024-03-01","source_url":"https://www.fdatracker.com/2024/03/phase-3-clinical-trials-with-primary-completion-dates-in-march-2024/","summary":"ACADIA Pharmaceuticals' Phase 3 trial for pimavanserin in schizophrenia completed primary data collection in March 2024."},{"ai_confidence":0.9,"created_at":"2026-05-07T00:46:56.379676","entity":"Aptevo","event_type":"product","id":"35436d58-6861-4029-aa87-4b49ec118308","impact":"high","pub_date":"2026-05-06","source_url":"https://www.panabee.com/fda","summary":"Aptevo reported 87% clinical benefit and 81% remission rates in 31 frontline AML patients in its RAINIER trial."},{"ai_confidence":0.95,"created_at":"2026-05-07T00:46:56.379661","entity":"Merck & Co., Inc.","event_type":"regulatory","id":"a197b324-76bc-4002-9d00-77e6c54b0c18","impact":"high","pub_date":"2026-04-01","source_url":"https://www.merck.com/news/merck-co-inc-rahway-n-j-usa-announces-first-quarter-2026-financial-results-highlights-significant-regulatory-approvals-and-clinical-milestones/","summary":"FDA accepted Merck's sBLA for WELIREG plus Lenvima for previously treated advanced RCC; PDUFA Oct. 4, 2026."},{"ai_confidence":0.95,"created_at":"2026-05-07T00:46:56.379582","entity":"Merck & Co., Inc.","event_type":"regulatory","id":"d367d062-b38d-4349-905c-2186bf5e61ee","impact":"high","pub_date":"2026-04-01","source_url":"https://www.merck.com/news/merck-co-inc-rahway-n-j-usa-announces-first-quarter-2026-financial-results-highlights-significant-regulatory-approvals-and-clinical-milestones/","summary":"FDA granted priority review for Merck's KEYTRUDA/KEYTRUDA QLEX with Padcev for cisplatin-eligible MIBC; PDUFA Aug. 17, 2026."},{"ai_confidence":0.95,"created_at":"2026-05-07T00:46:56.379400","entity":"Merck & Co., Inc.","event_type":"regulatory","id":"5fd76735-a0c8-4b8f-9004-a291b52f8141","impact":"high","pub_date":"2026-04-01","source_url":"https://www.merck.com/news/merck-co-inc-rahway-n-j-usa-announces-first-quarter-2026-financial-results-highlights-significant-regulatory-approvals-and-clinical-milestones/","summary":"FDA accepted Merck's sBLA for WELIREG + KEYTRUDA/KEYTRUDA QLEX for adjuvant RCC for priority review; PDUFA June 19, 2026."},{"ai_confidence":0.95,"created_at":"2026-05-06T00:31:49.838784","entity":"FDA","event_type":"regulatory","id":"c047da57-9853-4388-8bab-1fb059b3a427","impact":"high","pub_date":"2026-05-04","source_url":"https://www.nycdentalsociety.org/news-publications/nysda-publications/2026/05/04/fda-issues-regulatory-update","summary":"The FDA approved the first non-antipsychotic drug to treat agitation associated with dementia."},{"ai_confidence":0.9,"created_at":"2026-05-06T00:31:49.838775","entity":"FDA","event_type":"regulatory","id":"98bacfee-6c75-457a-98ed-32a5a02dd0d0","impact":"medium","pub_date":"2026-05-04","source_url":"https://www.nycdentalsociety.org/news-publications/nysda-publications/2026/05/04/fda-issues-regulatory-update","summary":"The FDA permitted expanded access for an investigational pancreatic cancer drug."},{"ai_confidence":0.95,"created_at":"2026-05-06T00:31:49.838766","entity":"FDA","event_type":"regulatory","id":"2313b00b-8fd5-4c5b-9f8a-907257673270","impact":"high","pub_date":"2026-05-01","source_url":"https://www.nycdentalsociety.org/news-publications/nysda-publications/2026/05/04/fda-issues-regulatory-update","summary":"The FDA approved Vepdegestrant for certain types of breast cancer."},{"ai_confidence":0.9,"created_at":"2026-05-06T00:31:49.838742","entity":"Amgen","event_type":"product","id":"9311265f-780e-4e04-9657-00b47270a2d0","impact":"low","pub_date":"2026-05-04","source_url":"https://hlth.com/insights/news/fda-launches-real-time-clinical-trials-pilot-with-astrazeneca-and-amgen","summary":"Amgen is participating in the FDA's real-time clinical trials pilot with a Phase Ib trial for small cell lung carcinoma."},{"ai_confidence":0.9,"created_at":"2026-05-06T00:31:49.838205","entity":"AstraZeneca","event_type":"product","id":"d26c3adc-3a3f-4246-bf19-983108afda53","impact":"low","pub_date":"2026-05-04","source_url":"https://hlth.com/insights/news/fda-launches-real-time-clinical-trials-pilot-with-astrazeneca-and-amgen","summary":"AstraZeneca is participating in the FDA's real-time clinical trials pilot with a Phase II trial for mantle cell lymphoma, with validated data signals."},{"ai_confidence":0.9,"created_at":"2026-05-06T00:31:49.838190","entity":"FDA","event_type":"regulatory","id":"7b43adcb-2570-49b2-bad7-d270343be2f5","impact":"medium","pub_date":"2026-05-04","source_url":"https://hlth.com/insights/news/fda-launches-real-time-clinical-trials-pilot-with-astrazeneca-and-amgen","summary":"The FDA launched a pilot program for real-time clinical trials to accelerate drug development."},{"ai_confidence":0.95,"created_at":"2026-05-05T00:16:56.976939","entity":"Summit Therapeutics","event_type":"product","id":"40477732-94a5-4def-914c-98cd2b234b5f","impact":"medium","pub_date":"2024-06-10","source_url":"https://allsci.com/news/clinical-trials/summits-ivonescimab-heads-toward-november-fda-decision-as-harmoni-3-interim-pfs-misses-threshold/","summary":"Interim PFS analysis for ivonescimab in the HARMONi-3 Phase III trial's squamous cohort did not meet statistical significance."},{"ai_confidence":0.98,"created_at":"2026-05-05T00:16:56.976931","entity":"Summit Therapeutics","event_type":"regulatory","id":"78f335c0-d8f8-4b05-b72e-407770c62f90","impact":"medium","pub_date":"2024-06-10","source_url":"https://allsci.com/news/clinical-trials/summits-ivonescimab-heads-toward-november-fda-decision-as-harmoni-3-interim-pfs-misses-threshold/","summary":"FDA accepted Summit's BLA for ivonescimab in EGFR-mutated NSCLC, setting a PDUFA date of November 14, 2026."},{"ai_confidence":0.98,"created_at":"2026-05-05T00:16:56.976923","entity":"Corcept Therapeutics Incorporated","event_type":"financial","id":"c0483bb8-e6d8-4f7e-b0a1-f97220488156","impact":"high","pub_date":"2024-06-10","source_url":"https://seekingalpha.com/article/4898079-corcept-strong-buy-on-lifyorli-fda-approval-and-als-phase-3-advancement","summary":"Corcept raised its 2026 revenue guidance to $950\u2013$1,050 million, driven by strong Lyforli uptake and robust Korlym sales."},{"ai_confidence":0.95,"created_at":"2026-05-05T00:16:56.976913","entity":"Corcept Therapeutics Incorporated","event_type":"product","id":"f2f1e8fc-65f3-4020-9dbd-c93b96ae8730","impact":"medium","pub_date":"2024-06-10","source_url":"https://seekingalpha.com/article/4898079-corcept-strong-buy-on-lifyorli-fda-approval-and-als-phase-3-advancement","summary":"Corcept plans a Phase 3 study for dazucorilant in ALS, targeting overall survival, following positive Phase 2 data."},{"ai_confidence":0.85,"created_at":"2026-05-05T00:16:56.976897","entity":"Corcept Therapeutics Incorporated","event_type":"regulatory","id":"04a90e41-aa84-4247-9366-1511fe75fb03","impact":"medium","pub_date":"2024-06-10","source_url":"https://seekingalpha.com/article/4898079-corcept-strong-buy-on-lifyorli-fda-approval-and-als-phase-3-advancement","summary":"FDA accepted NDA for Lyforli (relacorilant) plus nab-paclitaxel for platinum-resistant ovarian cancer, setting PDUFA date for July 11, 2026."},{"ai_confidence":0.9,"created_at":"2026-05-04T00:01:43.571525","entity":"AstraZeneca","event_type":"regulatory","id":"4f531f08-e2f0-4e07-8498-4584bfc629f3","impact":"medium","pub_date":"2024-05-20","source_url":"https://allsci.com/news/regulatory/fda-advisory-committee-recommends-astrazenecas-truqap-for-pten-deficient-prostate-cancer/","summary":"FDA's ODAC positively recommended AstraZeneca's Truqap (capivasertib) for PTEN-deficient metastatic hormone-sensitive prostate cancer."},{"ai_confidence":0.95,"created_at":"2026-05-04T00:01:43.571472","entity":"Arvinas Inc.","event_type":"regulatory","id":"93b5d8ea-a3f0-41e5-937f-e9375d2339a9","impact":"high","pub_date":"2024-05-20","source_url":"https://www.bioworld.com/articles/730770-first-protac-arvinas-veppanu-wins-fda-nod-in-breast-cancer?v=preview","summary":"Arvinas' vepdegestrant (Veppanu) received FDA approval for advanced or metastatic breast cancer, becoming the first PROTAC drug."},{"ai_confidence":0.9,"created_at":"2026-05-02T23:45:46.373290","entity":"Bristol-Myers Squibb","event_type":"regulatory","id":"5a4cf6b6-3c8e-4546-9156-5422fdb95fa4","impact":"medium","pub_date":"2026-02-01","source_url":"https://www.neurologyadvisor.com/news/fda-drug-approval-decisions-expected-in-march-2026/","summary":"FDA is expected to decide on the sNDA for deucravacitinib for the treatment of adults with active psoriatic arthritis by March 6, 2026."},{"ai_confidence":0.95,"created_at":"2026-05-02T23:45:46.373283","entity":"Merck & Co.","event_type":"regulatory","id":"f44204ad-921e-4f16-a5eb-878df60c9463","impact":"medium","pub_date":"2026-04-30","source_url":"https://www.msd.com/news/merck-co-inc-rahway-n-j-usa-announces-first-quarter-2026-financial-results-highlights-significant-regulatory-approvals-and-clinical-milestones/","summary":"FDA accepted for priority review supplemental applications for Merck's WELIREG with KEYTRUDA/QLEX for adjuvant RCC, PDUFA June 19, 2026."},{"ai_confidence":0.95,"created_at":"2026-05-02T23:45:46.373276","entity":"Merck & Co.","event_type":"regulatory","id":"caff2ce7-3acc-4659-bc42-59518801089a","impact":"medium","pub_date":"2026-04-30","source_url":"https://www.msd.com/news/merck-co-inc-rahway-n-j-usa-announces-first-quarter-2026-financial-results-highlights-significant-regulatory-approvals-and-clinical-milestones/","summary":"FDA accepted supplemental applications for Merck's WELIREG plus Lenvima in previously treated advanced RCC, with a PDUFA date of Oct. 4, 2026."},{"ai_confidence":0.95,"created_at":"2026-05-02T23:45:46.373270","entity":"Merck & Co.","event_type":"regulatory","id":"a2cf090a-ab2d-4bcf-91dc-83e0fd0afc38","impact":"medium","pub_date":"2026-04-30","source_url":"https://www.msd.com/news/merck-co-inc-rahway-n-j-usa-announces-first-quarter-2026-financial-results-highlights-significant-regulatory-approvals-and-clinical-milestones/","summary":"FDA granted priority review for Merck's KEYTRUDA and KEYTRUDA QLEX with Padcev for cisplatin-eligible MIBC, with a PDUFA date of Aug. 17, 2026."},{"ai_confidence":0.9,"created_at":"2026-05-02T23:45:46.373263","entity":"Merck & Co.","event_type":"financial","id":"7b8f3a3f-9456-4840-a248-ae8123e3cb03","impact":"medium","pub_date":"2026-04-30","source_url":"https://www.msd.com/news/merck-co-inc-rahway-n-j-usa-announces-first-quarter-2026-financial-results-highlights-significant-regulatory-approvals-and-clinical-milestones/","summary":"Merck & Co. announced its first-quarter 2026 financial results, highlighting significant regulatory approvals and clinical milestones."},{"ai_confidence":0.98,"created_at":"2026-05-02T23:45:46.373257","entity":"Arvinas, Pfizer","event_type":"regulatory","id":"5313e01f-4499-455e-bdca-6deb747a9aa8","impact":"high","pub_date":"2026-06-01","source_url":"https://www.quiverquant.com/news/Arvinas+and+Pfizer+Announce+FDA+Approval+of+VEPPANU%E2%84%A2+as+First-Ever+PROTAC+for+Advanced+Breast+Cancer+Treatment","summary":"Arvinas and Pfizer announced FDA approval for VEPPANU\u2122 (vepdegestrant) as the first PROTAC for advanced breast cancer treatment."},{"ai_confidence":0.9,"created_at":"2026-05-02T23:45:46.373250","entity":"Celcuity","event_type":"product","id":"48e13ae4-7a57-4d7e-b75a-7cf3283c2b7b","impact":"low","pub_date":"2026-01-01","source_url":"https://www.stocktitan.net/news/CELC/celcuity-s-phase-3-viktoria-1-trial-achieves-primary-endpoint-with-m8yxb6qj5hj9.html","summary":"Celcuity plans to present detailed Phase 3 VIKTORIA-1 trial data for gedatolisib at the ASCO 2026 Annual Meeting on June 2, 2026."},{"ai_confidence":0.95,"created_at":"2026-05-02T23:45:46.373241","entity":"Celcuity","event_type":"regulatory","id":"af454f7c-c6c3-4da5-9cd7-06126b53c2fe","impact":"medium","pub_date":"2026-01-01","source_url":"https://www.stocktitan.net/sec-filings/CELC/8-k-celcuity-inc-reports-material-event-a18ca0c4ce46.html","summary":"Celcuity's NDA for gedatolisib in PIK3CA wild-type disease is under FDA Priority Review with a PDUFA goal date of July 17, 2026."},{"ai_confidence":0.9,"created_at":"2026-05-02T23:45:46.373227","entity":"Celcuity","event_type":"regulatory","id":"aae625ef-85cc-4ffa-b2a8-5bdc6b982120","impact":"medium","pub_date":"2026-01-01","source_url":"https://www.stocktitan.net/sec-filings/CELC/8-k-celcuity-inc-reports-material-event-a18ca0c4ce46.html","summary":"Celcuity plans to submit a supplemental New Drug Application (sNDA) to the FDA for gedatolisib based on positive Phase 3 data."},{"ai_confidence":0.95,"created_at":"2026-05-02T23:45:46.373188","entity":"Celcuity","event_type":"product","id":"0ab555ae-b7af-4aca-877c-24b8b3c40744","impact":"high","pub_date":"2026-01-01","source_url":"https://www.stocktitan.net/sec-filings/CELC/8-k-celcuity-inc-reports-material-event-a18ca0c4ce46.html","summary":"Celcuity announced positive topline Phase 3 VIKTORIA-1 trial results for gedatolisib in PIK3CA mutant breast cancer, showing significant PFS improvement."},{"ai_confidence":0.98,"created_at":"2026-05-01T23:19:09.266418","entity":"Celcuity Inc.","event_type":"product","id":"0a56e1e9-ea86-4137-8470-16f0de69341c","impact":"high","pub_date":"2026-05-01","source_url":"https://markets.businessinsider.com/news/stocks/celcuity-s-phase-3-viktoria-1-trial-achieves-primary-endpoint-with-clinically-meaningful-improvement-in-progression-free-survival-in-pik3ca-mutant-cohort-1036096970","summary":"Celcuity's Phase 3 VIKTORIA-1 trial for gedatolisib in breast cancer met its primary endpoint, showing improved progression-free survival."},{"ai_confidence":0.95,"created_at":"2026-05-01T23:19:09.266375","entity":"FDA","event_type":"regulatory","id":"ab89565b-d94c-4ea5-91ae-e6846b3f42a1","impact":"high","pub_date":"2023-10-27","source_url":"https://www.fiercebiotech.com/biotech/fda-unveils-plan-real-time-review-clinical-trial-data-astrazeneca-and-amgen-already-board","summary":"FDA launched a pilot program for real-time clinical trial data review, with AstraZeneca and Amgen participating to accelerate drug development."},{"ai_confidence":0.95,"created_at":"2026-04-30T23:03:14.786893","entity":"Edesa Biotech, FDA","event_type":"regulatory","id":"b65a575e-383b-46b1-b6bd-3878be98758c","impact":"medium","pub_date":"2023-05-17","source_url":"https://finance.yahoo.com/news/edsa-fda-agrees-primary-endpoint-122200740.html","summary":"Edesa Biotech and the FDA agreed on the primary endpoint and population for a Phase 3 clinical trial evaluating EB05 for ARDS."},{"ai_confidence":0.9,"created_at":"2026-04-30T23:03:14.786886","entity":"US FDA","event_type":"regulatory","id":"5adf4bc2-b06c-44bc-832a-09f61eee95fe","impact":"low","pub_date":"2026-04-29","source_url":"https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-says-testing-reveals-domestic-infant-formula-supply-is-safe-2026-04-29/","summary":"The US FDA confirmed that domestic infant formula supply is safe for consumption after testing revealed very low contaminant levels."},{"ai_confidence":0.85,"created_at":"2026-04-30T23:03:14.786879","entity":"tab-cel","event_type":"product","id":"1be8fd0b-15e5-42a4-8481-3749a3fde8e3","impact":"medium","pub_date":"2026-01-01","source_url":"https://www.primetherapeutics.com/fda-decisions-expected-january-2026","summary":"The ALLELE trial showed a statistically significant objective response rate of 48.8% with tab-cel for relapsed or refractory EBV+ PTLD."},{"ai_confidence":0.85,"created_at":"2026-04-30T23:03:14.786871","entity":"Brimochol PF","event_type":"product","id":"8c511ede-a2ea-491e-96cb-8b7b20978224","impact":"medium","pub_date":"2026-01-01","source_url":"https://www.primetherapeutics.com/fda-decisions-expected-january-2026","summary":"Brimochol PF achieved its primary endpoint in a Phase 3 study, demonstrating significant gain in near visual acuity."},{"ai_confidence":0.9,"created_at":"2026-04-30T23:03:14.786862","entity":"Amphastar","event_type":"regulatory","id":"f51d527e-8242-4cdc-bd85-76045fb92401","impact":"medium","pub_date":"2026-01-01","source_url":"https://www.primetherapeutics.com/fda-decisions-expected-january-2026","summary":"Amphastar is awaiting an FDA decision for AMP-004, an insulin aspart biosimilar candidate to Novo Nordisk's Novolog."},{"ai_confidence":0.95,"created_at":"2026-04-30T23:03:14.786845","entity":"FDA, AstraZeneca, Amgen","event_type":"regulatory","id":"cec28685-80fe-4bf3-94dd-9f93a05e5b7a","impact":"high","pub_date":"2026-04-29","source_url":"https://www.clinicalresearchnewsonline.com/news/2026/04/29/fda-piloting-real-time-review-of-clinical-trial-data-from-astrazeneca--amgen","summary":"The FDA is piloting real-time review of clinical trial data from AstraZeneca and Amgen, utilizing AI to accelerate drug development and enhance safety."},{"ai_confidence":0.8,"created_at":"2026-04-29T22:49:14.759377","entity":"FDA","event_type":"regulatory","id":"f074aa87-90b9-44e6-b2d2-56e3c7c74045","impact":"low","pub_date":"2025-07-31","source_url":"https://www.primetherapeutics.com/fda-decisions-expected-august-2025","summary":"Prime Therapeutics published a calendar of anticipated FDA drug approval decisions expected in August 2025."},{"ai_confidence":1.0,"created_at":"2026-04-29T22:49:14.759342","entity":"FDA","event_type":"regulatory","id":"b706816c-e816-4f5a-8601-dd073d9a294a","impact":"high","pub_date":"2022-09-30","source_url":"https://www.fda.gov/media/191112/download","summary":"The FDA released its FY 2025 PDUFA Performance Report, noting PDUFA VII reauthorization by Congress on September 30, 2022."},{"ai_confidence":1.0,"created_at":"2026-04-29T22:49:14.759333","entity":"FDA","event_type":"regulatory","id":"fe1e36a5-d40a-414e-8c12-9842cb0dd19d","impact":"medium","pub_date":"2026-01-01","source_url":"https://www.fda.gov/media/190705/download?attachment","summary":"The FDA's 2025 report highlights 46 novel drug approvals, including 34 NMEs and 12 biologics, with half receiving Orphan Drug Designation."},{"ai_confidence":1.0,"created_at":"2026-04-29T22:49:14.759325","entity":"FDA","event_type":"regulatory","id":"9765dda2-3c33-453c-9255-16331326a39d","impact":"high","pub_date":"2025-12-04","source_url":"https://www.statnews.com/2025/12/04/fda-considers-single-clinical-trial-for-new-product-approvals/","summary":"The FDA plans to reduce the requirement for new drug approvals to a single clinical trial, aiming to speed development."},{"ai_confidence":0.9,"created_at":"2026-04-29T22:49:14.759315","entity":"Biopharma Industry","event_type":"regulatory","id":"935c967e-8d1d-461b-85ca-38f1f21c41ac","impact":"medium","pub_date":"2025-12-31","source_url":"https://www.fiercepharma.com/pharma/2025-drug-approvals","summary":"The biopharma industry achieved 55 new drug and biologic approvals from regulatory bodies in 2025."},{"ai_confidence":0.9,"created_at":"2026-04-29T22:49:14.759300","entity":"FDA","event_type":"regulatory","id":"0130a485-055b-4d65-9d7c-63ae64cb0a0c","impact":"medium","pub_date":"2025-12-31","source_url":"https://www.goodrx.com/drugs/news/upcoming-fda-approvals?srsltid=AfmBOoqIQliVXJe3zrpdDEYfANDpUdDK4CMJXQM027cobiFW7kYypvn8","summary":"FDA anticipates approving several novel drugs and new uses for existing therapies like Wegovy, Afrezza, and CagriSema in 2026."},{"ai_confidence":0.7,"created_at":"2026-04-28T22:34:42.544171","entity":"ARS Pharmaceuticals","event_type":"product","id":"1a79e782-c929-46f3-ae36-aad2193101bb","impact":"medium","pub_date":"2024-01-01","source_url":"https://www.goodrx.com/drugs/news/upcoming-fda-approvals?srsltid=AfmBOor8LXx3pKpg7eG_ad0EhMTZ_OqBix3pdDv1srnURF8NB-mnAGY","summary":"ARS Pharmaceuticals' Anaphylm (epinephrine film) is anticipated for first-time FDA approval in 2026."},{"ai_confidence":0.7,"created_at":"2026-04-28T22:34:42.544162","entity":"AstraZeneca","event_type":"product","id":"01493622-c1ca-41c4-8fd3-3560020d19fe","impact":"medium","pub_date":"2024-01-01","source_url":"https://www.goodrx.com/drugs/news/upcoming-fda-approvals?srsltid=AfmBOor8LXx3pKpg7eG_ad0EhMTZ_OqBix3pdDv1srnURF8NB-mnAGY","summary":"AstraZeneca's Saphnelo (anifrolumab) is anticipated for FDA approval for new uses, populations, or doses in 2026."},{"ai_confidence":0.7,"created_at":"2026-04-28T22:34:42.544152","entity":"MannKind Corporation","event_type":"product","id":"427a2289-8250-4cf8-8845-1e44650f3ece","impact":"medium","pub_date":"2024-01-01","source_url":"https://www.goodrx.com/drugs/news/upcoming-fda-approvals?srsltid=AfmBOor8LXx3pKpg7eG_ad0EhMTZ_OqBix3pdDv1srnURF8NB-mnAGY","summary":"MannKind's Afrezza (inhaled insulin) is anticipated for FDA approval for new uses, populations, or doses in 2026."},{"ai_confidence":0.75,"created_at":"2026-04-28T22:34:42.544136","entity":"Novo Nordisk","event_type":"product","id":"225621ad-8ebc-40b6-8205-9154c3089129","impact":"medium","pub_date":"2024-01-01","source_url":"https://www.goodrx.com/drugs/news/upcoming-fda-approvals?srsltid=AfmBOor8LXx3pKpg7eG_ad0EhMTZ_OqBix3pdDv1srnURF8NB-mnAGY","summary":"Novo Nordisk's Wegovy (new uses) and CagriSema (first-time) are anticipated for FDA approval in 2026."},{"ai_confidence":0.9,"created_at":"2026-04-27T22:18:03.244897","entity":"GoodRx","event_type":"announcement","id":"83656cbc-f48c-4f32-8c17-cbf5def7fbb2","impact":"low","pub_date":"2023-12-27","source_url":"https://www.goodrx.com/drugs/news/upcoming-fda-approvals?srsltid=AfmBOopRN_5mNoEKAdxuhcWVgK3ztOV8uCMfpVtBLUXq5kVGJn0fANjz","summary":"GoodRx announced a forecast of several highly anticipated drugs, including Wegovy and CagriSema, expected to receive FDA approval in 2026."},{"ai_confidence":0.9,"created_at":"2026-04-26T21:46:31.993874","entity":"Roche","event_type":"product","id":"8b69c49d-821e-4cad-9ab9-9c795a1b30b6","impact":"high","pub_date":"2024-05-15","source_url":"https://www.biotechreality.com/clinical-trials/clinical-data","summary":"Roche announced positive top-line Phase III METEOROID study results for Enspryng, showing delayed relapses in MOGAD patients."},{"ai_confidence":0.9,"created_at":"2026-04-26T21:46:31.993866","entity":"AstraZeneca","event_type":"product","id":"d8b50f6f-ec87-4bc0-94e4-cca84d8a7978","impact":"high","pub_date":"2024-05-15","source_url":"https://www.biotechreality.com/clinical-trials/clinical-data","summary":"AstraZeneca's Phase III MIRANDA trial for tozorakimab met its primary endpoint, marking its third positive pivotal study in COPD."},{"ai_confidence":0.95,"created_at":"2026-04-26T21:46:31.993856","entity":"Capricor Therapeutics","event_type":"regulatory","id":"349ad069-6348-4588-abc6-a8e605766d28","impact":"medium","pub_date":"2024-05-15","source_url":"https://www.stocktitan.net/news/CAPR/capricor-therapeutics-announces-late-breaking-presentation-of-hope-3-665luxw2mub7.html","summary":"Capricor Therapeutics' BLA for Deramiocel in Duchenne muscular dystrophy is under FDA review with a PDUFA date of August 22, 2026."},{"ai_confidence":0.95,"created_at":"2026-04-26T21:46:31.993817","entity":"Capricor Therapeutics","event_type":"product","id":"89f60c6c-44e5-41a4-8650-947b3f36f175","impact":"high","pub_date":"2024-05-15","source_url":"https://www.stocktitan.net/news/CAPR/capricor-therapeutics-announces-late-breaking-presentation-of-hope-3-665luxw2mub7.html","summary":"Capricor Therapeutics presented positive Phase 3 HOPE-3 results for Deramiocel in Duchenne muscular dystrophy, meeting the primary endpoint."},{"ai_confidence":0.8,"created_at":"2026-04-25T21:33:17.771308","entity":"Vera Therapeutics","event_type":"regulatory","id":"a0fba420-c7d8-48e1-872c-0e09297dbdd5","impact":"medium","pub_date":null,"source_url":"https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-us-fda-granted-priority-review","summary":"FDA granted Priority Review to Vera Therapeutics for an unspecified product."},{"ai_confidence":1.0,"created_at":"2026-04-25T21:33:17.771301","entity":"Vertex Pharmaceuticals Incorporated","event_type":"product","id":"b0209d0a-d8f7-4f63-996a-acce27f023d2","impact":"low","pub_date":"2025-10-17","source_url":"https://news.vrtx.com/news-releases/news-release-details/vertex-announces-progress-povetacicept-development-program-and","summary":"Vertex initiated a Phase 2b/3 trial for povetacicept in primary membranous nephropathy."},{"ai_confidence":1.0,"created_at":"2026-04-25T21:33:17.771294","entity":"Vertex Pharmaceuticals Incorporated","event_type":"regulatory","id":"48c0363b-a733-41da-bb0b-d4560e7b4b39","impact":"medium","pub_date":"2025-10-17","source_url":"https://news.vrtx.com/news-releases/news-release-details/vertex-announces-progress-povetacicept-development-program-and","summary":"FDA granted rolling review for Vertex's Biologics License Application (BLA) for povetacicept in IgA nephropathy."},{"ai_confidence":1.0,"created_at":"2026-04-25T21:33:17.771287","entity":"ImmunityBio","event_type":"regulatory","id":"36707b25-bc3c-470d-83ae-24bbbb18a76c","impact":"medium","pub_date":"2026-03-31","source_url":"https://www.targetedonc.com/view/fda-regulatory-highlights-in-oncology-march-2026","summary":"A supplemental BLA for nogapendekin alfa inbakicept-pmln (Anktiva) for NMIBC was resubmitted to the FDA."},{"ai_confidence":1.0,"created_at":"2026-04-25T21:33:17.771280","entity":"Bristol Myers Squibb","event_type":"regulatory","id":"955b16fb-1f4a-401c-a636-692afb085f04","impact":"high","pub_date":"2026-03-31","source_url":"https://www.targetedonc.com/view/fda-regulatory-highlights-in-oncology-march-2026","summary":"FDA approved nivolumab (Opdivo) for previously untreated stage III or IV classical Hodgkin lymphoma."},{"ai_confidence":1.0,"created_at":"2026-04-25T21:33:17.771271","entity":"Corcept Therapeutics Incorporated","event_type":"regulatory","id":"7aef3fb7-4fb5-417d-85e4-61cb4db9b247","impact":"high","pub_date":"2026-03-31","source_url":"https://www.targetedonc.com/view/fda-regulatory-highlights-in-oncology-march-2026","summary":"FDA approved relacorilant (Lifyorli) in combination with nab-paclitaxel for platinum-resistant ovarian cancer."},{"ai_confidence":1.0,"created_at":"2026-04-25T21:33:17.771262","entity":"Corcept Therapeutics Incorporated","event_type":"regulatory","id":"c3794306-c9c7-4592-89d0-ff5c03e91543","impact":"medium","pub_date":"2026-01-22","source_url":"https://ir.corcept.com/news-releases/news-release-details/overall-survival-primary-endpoint-met-corcepts-pivotal-phase-3","summary":"Corcept's NDA for relacorilant in ovarian cancer is under FDA review with a PDUFA target action date of July 11, 2026."},{"ai_confidence":1.0,"created_at":"2026-04-25T21:33:17.771244","entity":"Corcept Therapeutics Incorporated","event_type":"product","id":"9309ee00-486c-4078-ada8-f614c089ea1c","impact":"high","pub_date":"2026-01-22","source_url":"https://ir.corcept.com/news-releases/news-release-details/overall-survival-primary-endpoint-met-corcepts-pivotal-phase-3","summary":"Corcept's Phase 3 ROSELLA trial for relacorilant in platinum-resistant ovarian cancer met its primary endpoint of overall survival."},{"ai_confidence":0.85,"created_at":"2026-04-24T21:17:13.232326","entity":"Vera Therapeutics","event_type":"regulatory","id":"ee457505-ab80-4532-913e-3ea0add56d56","impact":"high","pub_date":"2024-01-01","source_url":"https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-us-fda-granted-priority-review/","summary":"Vera Therapeutics announced that the U.S. FDA granted Priority Review for an unspecified drug."},{"ai_confidence":0.98,"created_at":"2026-04-24T21:17:13.232316","entity":"Regeneron","event_type":"regulatory","id":"967a4713-32a3-411d-8f9f-b8e7ff874cf5","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":0.9,"created_at":"2026-04-24T21:17:13.232292","entity":"Arrowhead","event_type":"regulatory","id":"34eb0810-c2e6-41b5-a0e6-fccec1b49cf5","impact":"high","pub_date":"2026-04-20","source_url":"https://www.precisionmedicineonline.com/regulatory-news","summary":"EMA's CHMP recommended Arrowhead's FCS siRNA, moving it closer to marketing authorization."},{"ai_confidence":0.9,"created_at":"2026-04-24T21:17:13.230753","entity":"Novartis","event_type":"regulatory","id":"dd444822-a3c6-4d87-8d7f-e19b0eb8f0e7","impact":"high","pub_date":"2026-04-20","source_url":"https://www.precisionmedicineonline.com/regulatory-news","summary":"EMA's CHMP recommended Novartis' gene therapy for SMA, moving it closer to marketing authorization."},{"ai_confidence":0.95,"created_at":"2026-04-24T21:17:13.230745","entity":"Novartis","event_type":"regulatory","id":"4ac084ca-c712-444a-b65b-e202802d76b4","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 PSMA-positive prostate cancer due to trial concerns."},{"ai_confidence":0.85,"created_at":"2026-04-24T21:17:13.230737","entity":"CGBIO","event_type":"regulatory","id":"1407a197-64b8-4b79-a05c-50ad6e46e177","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 a patient-specific Ti product."},{"ai_confidence":0.95,"created_at":"2026-04-24T21:17:13.230729","entity":"Cocrystal Pharma","event_type":"product","id":"e99a8741-025e-4fb6-9d58-1480ed467b7d","impact":"high","pub_date":"2024-01-01","source_url":"https://biopharmiq-frontend.vercel.app/","summary":"Cocrystal Pharma (COCP) expects a Phase 1b data readout for CDI-988 (Coronavirus, Norovirus) on April 27, 2026."},{"ai_confidence":0.85,"created_at":"2026-04-24T21:17:13.230720","entity":"89bio, Inc.","event_type":"product","id":"4ac584aa-4672-4bd0-9e60-5ee9af373825","impact":"medium","pub_date":"2025-08-01","source_url":"https://www.fdatracker.com/2025/08/phase-3-clinical-trials-with-primary-completion-dates-in-august-2025/","summary":"89bio, Inc. expects primary completion of a Phase 3 clinical trial on August 1, 2025."},{"ai_confidence":0.95,"created_at":"2026-04-24T21:17:13.230709","entity":"Belite Bio, Inc.","event_type":"product","id":"324685d4-1c3b-4902-b4c9-426beaf89d4a","impact":"high","pub_date":"2025-08-01","source_url":"https://www.fdatracker.com/2025/08/phase-3-clinical-trials-with-primary-completion-dates-in-august-2025/","summary":"Belite Bio, Inc. expects primary completion of its Phase 3 trial for Tinlarebant in Stargardt Disease on August 1, 2025."},{"ai_confidence":0.95,"created_at":"2026-04-24T21:17:13.230663","entity":"Insmed","event_type":"regulatory","id":"f9ee4746-7165-402f-b6dc-4f9b184e245e","impact":"high","pub_date":"2025-01-01","source_url":"https://www.clinicalpainadvisor.com/news/fda-drug-approval-decisions-expected-in-august-2025/","summary":"FDA set August 12, 2025, as the PDUFA date for Insmed's Brensocatib for non-cystic fibrosis bronchiectasis."},{"ai_confidence":0.95,"created_at":"2026-04-23T21:10:13.432110","entity":"UroGen Pharma Ltd.","event_type":"regulatory","id":"322d0643-0e4b-4767-91b3-a1d6cf8818ce","impact":"high","pub_date":"2024-10-15","source_url":"https://investors.urogen.com/news-releases/news-release-details/urogen-announces-fda-acceptance-its-new-drug-application-ugn-102","summary":"UroGen announced FDA acceptance of its NDA for UGN-102 for LG-IR-NMIBC, with a PDUFA goal date set for June 13, 2025."},{"ai_confidence":0.95,"created_at":"2026-04-23T21:10:13.432102","entity":"Mineralys Therapeutics","event_type":"regulatory","id":"de2484bd-819c-4de4-a8ba-cd971e72c0d8","impact":"high","pub_date":"2026-03-09","source_url":"https://www.biospace.com/press-releases/mineralys-therapeutics-announces-fda-acceptance-of-nda-for-lorundrostat-for-treatment-of-adults-with-hypertension-and-topline-explore-osa-trial-results","summary":"Mineralys Therapeutics announced FDA acceptance of its NDA for lorundrostat for hypertension and topline Explore-OSA trial results."},{"ai_confidence":0.95,"created_at":"2026-04-23T21:10:13.432090","entity":"Aldeyra Therapeutics, Inc.","event_type":"regulatory","id":"5ff76bc2-41c4-4edf-a9c6-d0ee0964ff54","impact":"medium","pub_date":"2025-12-15","source_url":"https://ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-announces-pdufa-extension-new-drug","summary":"Aldeyra Therapeutics announced the FDA extended the PDUFA target action date for reproxalap for dry eye disease to March 16, 2026."},{"ai_confidence":0.95,"created_at":"2026-04-23T21:10:13.432018","entity":"Bristol Myers Squibb","event_type":"regulatory","id":"e2cc1a75-862c-45ae-b3eb-4dc688cfc402","impact":"high","pub_date":"2026-03-01","source_url":"https://www.patientcareonline.com/view/5-fda-decisions-for-primary-care-to-know-from-march-2026","summary":"Bristol Myers Squibb's deucravacitinib (Sotyktu) received FDA approval for active psoriatic arthritis based on Phase 3 trials."},{"ai_confidence":0.95,"created_at":"2026-04-23T21:10:13.432008","entity":"Novo Nordisk","event_type":"regulatory","id":"2e3fbcf5-2811-4402-bb1b-086578d59ecd","impact":"high","pub_date":"2026-03-01","source_url":"https://www.patientcareonline.com/view/5-fda-decisions-for-primary-care-to-know-from-march-2026","summary":"Novo Nordisk's semaglutide 7.2 mg (Wegovy HD) was FDA approved for obesity, showing 20.7% mean weight loss in trials."},{"ai_confidence":0.95,"created_at":"2026-04-23T21:10:13.431998","entity":"Johnson & Johnson","event_type":"regulatory","id":"3b091f15-f520-4d19-9cd5-664b3ef57e9c","impact":"high","pub_date":"2026-03-01","source_url":"https://www.patientcareonline.com/view/5-fda-decisions-for-primary-care-to-know-from-march-2026","summary":"Johnson & Johnson's icotrokinra (Icotyde) was FDA approved for moderate-to-severe plaque psoriasis based on Phase 3 data."},{"ai_confidence":0.85,"created_at":"2026-04-23T21:10:13.431990","entity":"AbbVie","event_type":"product","id":"90f2459b-c386-4684-9e47-608e5549e994","impact":"high","pub_date":"2026-04-16","source_url":"https://www.biotechreality.com/tag/phase-3-trial","summary":"AbbVie announced positive Phase 3 AFFIRM study results for Risankizumab (SKYRIZI\u00ae) in Crohn's Disease, achieving superiority."},{"ai_confidence":0.85,"created_at":"2026-04-23T21:10:13.431982","entity":"Roche","event_type":"product","id":"49e5fded-2918-489f-8a52-6a83b0461853","impact":"high","pub_date":"2026-04-16","source_url":"https://www.biotechreality.com/tag/phase-3-trial","summary":"Roche's Gazyva met its primary endpoint in the Phase III ALLEGORY study for lupus, demonstrating significant disease control."},{"ai_confidence":0.85,"created_at":"2026-04-23T21:10:13.431974","entity":"Eli Lilly and Company","event_type":"product","id":"ba93073b-bd9c-44ac-8030-b744be714dfc","impact":"high","pub_date":"2026-04-16","source_url":"https://www.biotechreality.com/tag/phase-3-trial","summary":"Eli Lilly's EBGLYSS (lebrikizumab) showed positive Phase 3 results for pediatric atopic dermatitis, achieving 63% EASI-75 skin improvement."},{"ai_confidence":0.9,"created_at":"2026-04-23T21:10:13.431965","entity":"Axsome Therapeutics Inc.","event_type":"regulatory","id":"c972f070-fb09-40fe-85fc-eb4c954d8cb9","impact":"medium","pub_date":"2026-04-30","source_url":"https://app.bpiq.com/pdufa-calendar","summary":"Axsome Therapeutics' AXS-05 for Alzheimer's disease has a PDUFA approval decision date of April 30, 2026."},{"ai_confidence":0.9,"created_at":"2026-04-23T21:10:13.431948","entity":"Grace Therapeutics","event_type":"regulatory","id":"76b00bb9-3f4c-4bec-943f-4c999b608238","impact":"medium","pub_date":"2026-04-23","source_url":"https://app.bpiq.com/pdufa-calendar","summary":"Grace Therapeutics' GTx-104 for aSAH has a PDUFA approval decision date of April 23, 2026, after meeting its primary endpoint."},{"ai_confidence":0.9,"created_at":"2026-04-20T03:22:09.833142","entity":"Multiple pharmaceutical companies","event_type":"regulatory","id":"ac9d1bdb-3cc6-4ed3-ab5e-f57dd6a3e95d","impact":"high","pub_date":"2026-01-01","source_url":"https://www.drugs.com/newdrugs.html","summary":"The FDA approved several new drugs in 2026, including Foundayo, Kresladi, Awiqli, Lifyorli, and Avlayah for various conditions."},{"ai_confidence":0.95,"created_at":"2026-04-20T03:22:09.833136","entity":"Capricor Therapeutics","event_type":"regulatory","id":"21ae3f48-77bc-4d25-a6e1-f99a4d2fd9f0","impact":"medium","pub_date":"2026-01-20","source_url":"https://www.capricor.com/investors/news-events/press-releases/detail/335/capricor-therapeutics-provides-regulatory-update-on","summary":"Capricor Therapeutics provided a regulatory update on its Deramiocel BLA, with the FDA requesting the HOPE-3 clinical study report."},{"ai_confidence":0.98,"created_at":"2026-04-20T03:22:09.833130","entity":"Vertex Pharmaceuticals","event_type":"product","id":"65ad295a-3318-452f-b571-237b43848f08","impact":"high","pub_date":"2026-03-09","source_url":"https://news.vrtx.com/news-releases/news-release-details/vertex-announces-positive-week-36-interim-analysis-results","summary":"Vertex Pharmaceuticals announced positive Week 36 interim Phase 3 RAINIER trial results for povetacicept in IgA Nephropathy."},{"ai_confidence":0.95,"created_at":"2026-04-20T03:22:09.833124","entity":"Arrowhead Pharmaceuticals","event_type":"regulatory","id":"8bc2ee6d-4a56-40a1-a637-5a8e82e25c84","impact":"medium","pub_date":"2025-11-18","source_url":"https://www.empr.com/news/fda-drug-approval-decisions-expected-in-november-2025/","summary":"Arrowhead Pharmaceuticals' NDA for plozasiran for familial chylomicronemia syndrome is under FDA review with a PDUFA date of November 18, 2025."},{"ai_confidence":0.98,"created_at":"2026-04-20T03:22:09.833119","entity":"Protagonist Therapeutics","event_type":"product","id":"c3153fa7-8676-493e-b051-9ba3b2484b5f","impact":"high","pub_date":"2025-03-03","source_url":"https://www.takeda.com/newsroom/newsreleases/2025/positive-topline-results-from-verify-study/","summary":"Protagonist Therapeutics and Takeda announced positive topline Phase 3 VERIFY study results for rusfertide in polycythemia vera."},{"ai_confidence":0.95,"created_at":"2026-04-20T03:22:09.833113","entity":"Larimar Therapeutics","event_type":"regulatory","id":"ce0277ed-c606-4e11-87f9-dc699c37e9b4","impact":"high","pub_date":"2024-05-15","source_url":"https://investors.larimartx.com/news-releases/news-release-details/larimar-therapeutics-announces-fda-breakthrough-therapy","summary":"Larimar Therapeutics received FDA Breakthrough Therapy Designation for nomlabofusp in FA and plans BLA submission in June 2026."},{"ai_confidence":0.98,"created_at":"2026-04-20T03:22:09.833107","entity":"Orca Bio","event_type":"regulatory","id":"63bac5f3-4958-44c1-a21a-4204e16e5a2f","impact":"high","pub_date":"2025-10-06","source_url":"https://www.gastroenterologyadvisor.com/news/fda-drug-approval-decisions-expected-in-april-2026/","summary":"Orca Bio's BLA for Orca-T, an immunotherapy for hematological malignancies, received FDA Priority Review with a PDUFA date of April 6, 2026."},{"ai_confidence":0.9,"created_at":"2026-04-20T03:22:09.833101","entity":"Avecho Biotechnology Limited","event_type":"product","id":"e00151ce-8c9e-406e-87b4-ef87c3923bdf","impact":"low","pub_date":"2025-12-01","source_url":"https://www.fdatracker.com/2025/12/phase-3-clinical-trials-with-primary-completion-dates-in-december-2025/","summary":"Avecho Biotechnology Limited's Phase 3 trial for an unspecified drug has a primary completion date of December 1, 2025."},{"ai_confidence":0.9,"created_at":"2026-04-20T03:22:09.833095","entity":"Ascentage Pharma Group International","event_type":"product","id":"8b5dde9f-3c9f-4784-b4f8-8ee459739eb5","impact":"low","pub_date":"2025-12-01","source_url":"https://www.fdatracker.com/2025/12/phase-3-clinical-trials-with-primary-completion-dates-in-december-2025/","summary":"Ascentage Pharma Group International's Phase 3 trial for Olverembatinib (CP-CML) has a primary completion date of December 1, 2025."},{"ai_confidence":0.98,"created_at":"2026-04-20T03:22:09.833089","entity":"Genmab","event_type":"product","id":"ec38d3ce-704a-4979-a622-39f05ea850a4","impact":"high","pub_date":"2025-08-07","source_url":"https://ir.genmab.com/news-releases/news-release-details/genmab-announces-phase-3-epcorer-fl-1-clinical-trial-met-dual/","summary":"Genmab's epcoritamab met dual primary endpoints in Phase 3 FL-1 trial for follicular lymphoma, leading to FDA Priority Review with a PDUFA date of November 30, 2025."},{"ai_confidence":0.95,"created_at":"2026-04-20T03:22:09.833082","entity":"Revolution Medicines","event_type":"product","id":"3176b04b-c3d7-4717-a7ed-5542b0be637d","impact":"high","pub_date":"2026-04-13","source_url":"https://www.biospace.com/phase-iii-clinical-trials","summary":"Revolution Medicines' pancreatic cancer drug achieved a significant improvement in survival in Phase 3 trials, supporting global regulatory filings."},{"ai_confidence":0.98,"created_at":"2026-04-20T03:22:09.833061","entity":"Genentech","event_type":"product","id":"f9fa4d9d-3b4d-4755-afbe-de395f7cbec1","impact":"high","pub_date":"2025-11-09","source_url":"https://www.gene.com/media/press-releases/15089/2025-11-09/genentechs-fenebrutinib-shows-unpreceden","summary":"Genentech's fenebrutinib met its primary endpoint in a Phase III RMS study, significantly reducing relapses in multiple sclerosis."},{"ai_confidence":0.98,"created_at":"2026-04-20T03:22:09.832394","entity":"Priovant Therapeutics","event_type":"regulatory","id":"02159521-be83-41c4-bc2f-bac2b8696bc5","impact":"high","pub_date":"2026-03-03","source_url":"https://investor.roivant.com/news-releases/news-release-details/priovant-announces-fda-acceptance-and-priority-review-new-drug/","summary":"Priovant Therapeutics announced FDA acceptance and Priority Review for its brepocitinib NDA for dermatomyositis, with a PDUFA date in Q3 2026."},{"ai_confidence":0.98,"created_at":"2026-04-20T03:22:09.832382","entity":"Capricor Therapeutics","event_type":"regulatory","id":"fdad2634-be7d-45d4-8ad5-8f2f50277359","impact":"medium","pub_date":"2026-03-10","source_url":"https://www.capricor.com/investors/news-events/press-releases/detail/338/capricor-therapeutics-announces-establishment-of-new-pdufa","summary":"Capricor Therapeutics announced a PDUFA target action date of August 22, 2026, for its Deramiocel BLA for Duchenne muscular dystrophy."},{"ai_confidence":0.95,"created_at":"2026-04-20T03:22:09.832375","entity":"US Government","event_type":"regulatory","id":"df4c2ceb-fba2-4999-8d2a-7eb3f4fef7af","impact":"high","pub_date":"2022-09-30","source_url":"https://www.fda.gov/about-fda/fda-track-agency-wide-program-performance/fda-track-prescription-drug-user-fee-act-pdufa-performance-reports","summary":"The President signed the FDA User Fee Reauthorization Act of 2022 (FUFRA), reauthorizing PDUFA VII for FY 2023-2027."},{"ai_confidence":0.95,"created_at":"2026-04-20T03:22:09.832370","entity":"Eli Lilly","event_type":"regulatory","id":"e9908ae5-6203-4b7d-ab3b-4050acae9c7d","impact":"medium","pub_date":"2026-02-13","source_url":"https://www.intelacia.com/2026/02/13/5-fda-drug-approvals-that-could-shape-biotech-in-2026/","summary":"The FDA rescheduled the target action date for Eli Lilly's Phase 3 obesity drug, Orforglipron, to April 10, 2026."},{"ai_confidence":0.9,"created_at":"2026-04-20T03:22:09.832355","entity":"FDA","event_type":"regulatory","id":"bb1e9e71-7333-4a48-bdc4-818efad8c61b","impact":"medium","pub_date":"2024-05-15","source_url":"https://www.fiercebiotech.com/biotech/fda-urges-clinical-trial-sponsors-report-results-their-studies","summary":"The FDA urged over 2,200 drug companies and researchers to report their clinical trial results, noting 30% non-compliance."},{"ai_confidence":0.95,"created_at":"2026-04-05T03:40:20.823749","entity":"Cipla USA Inc.","event_type":"regulatory","id":"dbba4396-ac2a-4ec9-9562-a86de3baec1f","impact":"medium","pub_date":"2024-04-01","source_url":"https://www.prnewswire.com/news-releases/cipla-expands-us-respiratory-portfolio-with-approval-of-nintedanib-capsules-100mg--150mg-for-idiopathic-pulmonary-fibrosis-302404001.html","summary":"Cipla USA received FDA approval for its generic Nintedanib Capsules, a therapeutic equivalent to Boehringer Ingelheim's Ofev for IPF."},{"ai_confidence":0.95,"created_at":"2026-04-05T03:40:20.823741","entity":"Eli Lilly","event_type":"regulatory","id":"0a8fa829-01d3-4097-b1c6-f52832c41860","impact":"high","pub_date":"2024-03-01","source_url":"https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program","summary":"FDA approved Eli Lilly's Foundayo (orforglipron) for chronic weight management, marking the fastest NME approval since 2002."},{"ai_confidence":0.95,"created_at":"2026-04-05T03:40:20.823725","entity":"Novo Nordisk","event_type":"regulatory","id":"8deca324-1868-4144-8509-aa1980a8300c","impact":"high","pub_date":"2024-03-01","source_url":"https://www.medscape.com/viewarticle/fda-approves-first-once-weekly-insulin-type-2-diabetes-2026a1000001","summary":"FDA approved Novo Nordisk's Awiqli, the first once-weekly basal insulin for type 2 diabetes, supported by Phase 3 data."},{"ai_confidence":0.99,"created_at":"2026-04-05T03:26:47.623478","entity":"GSK","event_type":"regulatory","id":"b2e34a93-7698-4fc7-be15-8781d5ddac57","impact":"high","pub_date":"2024-05-22","source_url":"https://www.fiercepharma.com/pharma/regulatory-tracker-vertex-secures-broader-fda-labels-cystic-fibrosis-meds-alyftrek-trikafta","summary":"GSK's Exdensur was approved in China for severe asthma following successful Phase 3 trials."},{"ai_confidence":0.95,"created_at":"2026-04-05T03:26:47.623455","entity":"Agios Pharmaceuticals","event_type":"regulatory","id":"6fe059d9-d538-4f84-96ed-c1449320700a","impact":"medium","pub_date":"2024-05-22","source_url":"https://www.fiercepharma.com/pharma/regulatory-tracker-vertex-secures-broader-fda-labels-cystic-fibrosis-meds-alyftrek-trikafta","summary":"Agios Pharmaceuticals is pursuing accelerated FDA approval for Pyrukynd in sickle cell disease."},{"ai_confidence":0.99,"created_at":"2026-04-05T03:26:47.523986","entity":"Novo Nordisk","event_type":"regulatory","id":"b06b085a-7f37-4f96-9f5c-61b2740f31fd","impact":"high","pub_date":"2024-05-22","source_url":"https://www.fiercepharma.com/pharma/regulatory-tracker-vertex-secures-broader-fda-labels-cystic-fibrosis-meds-alyftrek-trikafta","summary":"Novo Nordisk's once-weekly Awiqli received FDA approval for Type 2 diabetes based on Phase 3a clinical data."},{"ai_confidence":0.98,"created_at":"2026-04-05T03:26:47.523979","entity":"Viatris","event_type":"regulatory","id":"c89121f1-b2f2-45c1-84cd-4ffa2a47470c","impact":"medium","pub_date":"2024-05-22","source_url":"https://www.fiercepharma.com/pharma/regulatory-tracker-vertex-secures-broader-fda-labels-cystic-fibrosis-meds-alyftrek-trikafta","summary":"Viatris' Ryzumvi eye drop application for presbyopia was accepted by the FDA, with a PDUFA date in October 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T03:26:47.523972","entity":"Viridian Therapeutics","event_type":"regulatory","id":"e6dd7fd7-9807-48a6-9a7b-a4aae471adf7","impact":"medium","pub_date":"2024-05-22","source_url":"https://ir.viridiantherapeutics.com/news-releases/news-release-details/viridian-therapeutics-announces-positive-topline-results","summary":"Viridian Therapeutics' candidate veligrotug has a PDUFA target action date of June 30, 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T03:26:47.523965","entity":"Viridian Therapeutics","event_type":"regulatory","id":"09625919-bf41-4b26-901c-e6e7938d45a1","impact":"medium","pub_date":"2024-05-22","source_url":"https://ir.viridiantherapeutics.com/news-releases/news-release-details/viridian-therapeutics-announces-positive-topline-results","summary":"Viridian Therapeutics anticipates submitting a Biologics License Application (BLA) for elegrobart in Q1 2027."},{"ai_confidence":0.98,"created_at":"2026-04-05T03:26:47.523949","entity":"Viridian Therapeutics","event_type":"product","id":"5eaf82da-4e84-440c-91c6-057d23e45094","impact":"high","pub_date":"2024-05-22","source_url":"https://ir.viridiantherapeutics.com/news-releases/news-release-details/viridian-therapeutics-announces-positive-topline-results","summary":"Viridian Therapeutics announced positive topline results from its Phase 3 REVEAL-1 clinical trial for elegrobart in active Thyroid Eye Disease."}]