[{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291930","entity":"roflumilast cream","event_type":"regulatory","id":"c45e4946-ca25-4081-aee5-b57baf8e7d42","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.hcplive.com/view/q2-2026-preview-6-fda-decisions-to-watch","summary":"Upcoming FDA decision for roflumilast cream for pediatric plaque psoriasis expected in Q2 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291924","entity":"baxdrostat","event_type":"regulatory","id":"e0debace-8379-4b54-8c57-b2278e8302bb","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.hcplive.com/view/q2-2026-preview-6-fda-decisions-to-watch","summary":"Upcoming FDA decision for baxdrostat for hypertension expected in Q2 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291917","entity":"olezarsen","event_type":"regulatory","id":"356a6fae-bd1b-4098-8b18-3e6a13de8d72","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.hcplive.com/view/q2-2026-preview-6-fda-decisions-to-watch","summary":"Upcoming FDA decision for olezarsen for severe hypertriglyceridemia expected in Q2 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291910","entity":"cytisinicline","event_type":"regulatory","id":"57abe1bd-25a4-4f72-98d1-e404db5fb8b4","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.hcplive.com/view/q2-2026-preview-6-fda-decisions-to-watch","summary":"Upcoming FDA decision for cytisinicline for smoking cessation expected in Q2 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291903","entity":"inhaled insulin","event_type":"regulatory","id":"0865c31a-4ecb-46a9-9ff2-8eb9a7ab3731","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.hcplive.com/view/q2-2026-preview-6-fda-decisions-to-watch","summary":"Upcoming FDA decision for inhaled insulin for pediatric patients expected in Q2 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291884","entity":"sparsentan","event_type":"regulatory","id":"a45ffc5e-9eed-45e7-9036-0a6ed2d95040","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.hcplive.com/view/q2-2026-preview-6-fda-decisions-to-watch","summary":"Upcoming FDA decision for sparsentan in focal segmental glomerulosclerosis expected in Q2 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.291877","entity":"Praxis Precision Medicines","event_type":"regulatory","id":"3afa01c1-3ba6-414b-97ee-dcdd25490dbb","impact":"high","pub_date":"2026-03-01","source_url":"https://www.stocktitan.net/news/PRAX/praxis-precision-medicines-announces-fda-acceptance-and-priority-p83rejsk7rol.html","summary":"Praxis Precision Medicines announced FDA acceptance and priority review of NDA for relutrigine for SCN2A and SCN8A DEEs."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.291870","entity":"Egetis Therapeutics","event_type":"regulatory","id":"fd20accc-0a07-49cd-b066-4fa0e8877cc5","impact":"high","pub_date":"2026-03-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQGl5ssk-heTGQqP8YXo3E1CW2sAP3UWYWKLfMg-hNm4pxJi43kfSVJ1mFHioeiqFULJUQ2alO4WPi2qCc75LbJHsJJvJ3_iUrAY0ZdR2TbXn0jyRHGu5zG17KPhSUaTgDEXWziVB1MJegyHAoFKM0xywV_uVL4BU2SGLgt_F4gg6bi81kRwD7thG2RPXW2PRkNG0eamx9Vg0EEL7uK4UMmmm6Y3BaMnyvC3pIcL-dfrt_LZG3qn2UYDe8tE2ja-WUDeT2ud_tz8l_ISgg==","summary":"Egetis Therapeutics announced FDA acceptance and priority review of NDA for Emcitate (tiratricol) for MCT8 deficiency."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291863","entity":"RP1","event_type":"regulatory","id":"230bac47-846a-41ec-812d-b638fa3bfd43","impact":"medium","pub_date":"2026-04-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQEsZdQgnNjTd_3P40ZY4-377QMNjfDSDWieJrh33E4Kq42hI78TsgFm96FHCaCSyNGcpbCmLNiExCKjzS0LYMIrm5dEyaSeldRsOGmYRX5s-IVGtyufvDrnHxdFvzlZlGoil5tdPArQiWs4IUOohyiG_1Qh_03IZWryiu5AZF-B7hD6ucYHFOz2","summary":"Upcoming FDA complete response letter for RP1 in advanced melanoma expected in Q2 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291855","entity":"trastuzumab deruxtecan","event_type":"regulatory","id":"ef15ade4-b81f-4ecd-b44b-51843b552c5d","impact":"medium","pub_date":"2026-04-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQEsZdQgnNjTd_3P40ZY4-377QMNjfDSDWieJrh33E4Kq42hI78TsgFm96FHCaCSyNGcpbCmLNiExCKjzS0LYMIrm5dEyaSeldRsOGmYRX5s-IVGtyufvDrnHxdFvzlZlGoil5tdPArQiWs4IUOohyiG_1Qh_03IZWryiu5AZF-B7hD6ucYHFOz2","summary":"Upcoming FDA decision on sBLA for trastuzumab deruxtecan in HER2-positive early breast cancer expected in Q2 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291833","entity":"vepdegestrant","event_type":"regulatory","id":"7fdbe694-6f84-4976-942d-034f07046b8a","impact":"medium","pub_date":"2026-04-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQEsZdQgnNjTd_3P40ZY4-377QMNjfDSDWieJrh33E4Kq42hI78TsgFm96FHCaCSyNGcpbCmLNiExCKjzS0LYMIrm5dEyaSeldRsOGmYRX5s-IVGtyufvDrnHxdFvzlZlGoil5tdPArQiWs4IUOohyiG_1Qh_03IZWryiu5AZF-B7hD6ucYHFOz2","summary":"Upcoming FDA decision on NDA for vepdegestrant for ESR1-mutant breast cancer expected in Q2 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291813","entity":"sonrotoclax","event_type":"regulatory","id":"1afd5267-4ab6-41bf-a95f-f242e42d81a0","impact":"medium","pub_date":"2026-04-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQEsZdQgnNjTd_3P40ZY4-377QMNjfDSDWieJrh33E4Kq42hI78TsgFm96FHCaCSyNGcpbCmLNiExCKjzS0LYMIrm5dEyaSeldRsOGmYRX5s-IVGtyufvDrnHxdFvzlZlGoil5tdPArQiWs4IUOohyiG_1Qh_03IZWryiu5AZF-B7hD6ucYHFOz2","summary":"Upcoming FDA decision on NDA for sonrotoclax in relapsed/refractory mantle cell lymphoma expected in Q2 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.291806","entity":"Elevar Therapeutics","event_type":"regulatory","id":"b4c6bcd8-93be-485a-ba27-bcf97f0948ce","impact":"high","pub_date":"2026-03-01","source_url":"https://www.onclive.com/view/fda-grants-priority-review-to-lirafugratinib-for-fgfr2-pretreated-cholangiocarcinoma","summary":"FDA granted priority review to Elevar Therapeutics' NDA for lirafugratinib for pretreated cholangiocarcinoma, with a PDUFA date of Sept 27, 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.291799","entity":"Soficabtagene geleucel (WU-CART-007)","event_type":"regulatory","id":"434dd05c-bfae-4a5e-b6da-cd2ef60851ef","impact":"high","pub_date":"2026-03-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQGe9agtljSOsT0tQmLWsA26N0dRrR0_YQMdn_SoLkIcVwIkhPYKKV7U59KGjGddF4YUr4gwiXzPxVx5nxqkd59WS9yDaHoyypLDzi_HuhBrXdumdq-H-8__Sl5CJqH-1WwG2LVnwJWugiCCK5yMUQxjMzGybQ3ooNAETvr1bXep9jJAeIC1BdyE3kJjBRIS7IBmRlPqgjEvHBwTPBk7LWJJb5AD8-oPJqoukkRY-ZUVLfZ8ksTT30TC6jECPEE=","summary":"FDA granted Breakthrough Therapy Designation to Soficabtagene geleucel (WU-CART-007) for relapsed or refractory T-cell leukemia and lymphoma."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.291790","entity":"FDA","event_type":"announcement","id":"1134927d-c96b-4572-89a2-0f7974aacfe7","impact":"medium","pub_date":"2026-03-01","source_url":"https://www.medpagetoday.com/publichealthpolicy/fdageneral/120604","summary":"FDA Commissioner Marty Makary announced that speeding up drug approvals and increasing OTC drug availability are key agency priorities."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.291761","entity":"trastuzumab deruxtecan","event_type":"regulatory","id":"db250571-94c1-49be-a0e3-8f44b54a7350","impact":"high","pub_date":"2026-03-01","source_url":"https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-march-2026","summary":"FDA fast-tracked and granted priority review to trastuzumab deruxtecan for HER2-positive early breast cancer in March 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.291726","entity":"rusfertide","event_type":"regulatory","id":"deafdbb2-f7d3-48d8-a925-b44a178e934c","impact":"high","pub_date":"2026-03-01","source_url":"https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-march-2026","summary":"FDA fast-tracked and granted priority review to rusfertide for polycythemia vera in March 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.290500","entity":"lirafugratinib","event_type":"regulatory","id":"dd3c7813-8e56-48a4-8d76-7cf6cccd52e8","impact":"high","pub_date":"2026-03-01","source_url":"https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-march-2026","summary":"FDA fast-tracked and granted priority review to lirafugratinib for cholangiocarcinoma in March 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.290493","entity":"luvesilocin","event_type":"regulatory","id":"175a403c-64b8-4c86-86c3-a70451c115f8","impact":"high","pub_date":"2026-03-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQEZAvWP00QpRR-39U-gT_5-IiZP5jTRg37Z6s4ch47WXH7zC3UbrGLBQp3aQ_IjAgCsLUAnPhpzJyOoBxTDvyydwlRveYZjFniMkFR2okSjL-XXuECYlqVjx9FlOWkBckIKnOfWu1iYvHN_epj1y_mx230r9btzRkqqEDF","summary":"FDA granted Breakthrough Therapy Designation to luvesilocin for postpartum depression (PPD)."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.290486","entity":"milsaperidone","event_type":"regulatory","id":"34f3256e-730c-4dd2-ac70-2ca7a0cde590","impact":"high","pub_date":"2026-03-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQEZAvWP00QpRR-39U-gT_5-IiZP5jTRg37Z6s4ch47WXH7zC3UbrGLBQp3aQ_IjAgCsLUAnPhpzJyOoBxTDvyydwlRveYZjFniMkFR2okSjL-XXuECYlqVjx9FlOWkBckIKnOfWu1iYvHN_epj1y_mx230r9btzRkqqEDF","summary":"FDA approved milsaperidone for schizophrenia and bipolar 1."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.290479","entity":"Avlayah","event_type":"regulatory","id":"37b34aba-aa91-4113-a383-abe5aa6f7cba","impact":"high","pub_date":"2026-03-01","source_url":"https://www.drugs.com/newdrugs.html","summary":"FDA approved Avlayah for Hunter Syndrome in 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.290472","entity":"Lifyorli","event_type":"regulatory","id":"9e3573e7-2b87-48d0-9090-be429858010f","impact":"high","pub_date":"2026-03-01","source_url":"https://www.drugs.com/newdrugs.html","summary":"FDA approved Lifyorli for platinum-resistant ovarian cancer in 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.290464","entity":"Awiqli (insulin icodec-abae)","event_type":"regulatory","id":"69b740d2-679b-4949-8432-2d18a10474a9","impact":"high","pub_date":"2026-03-01","source_url":"https://www.drugs.com/newdrugs.html","summary":"FDA approved Awiqli (insulin icodec-abae) for type 2 diabetes in 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.290437","entity":"Kresladi (marnetegragene autotemcel)","event_type":"regulatory","id":"50b46620-1159-4ef2-b0ed-782e55f9de9c","impact":"high","pub_date":"2026-03-01","source_url":"https://www.drugs.com/newdrugs.html","summary":"FDA approved Kresladi (marnetegragene autotemcel) for severe Leukocyte Adhesion Deficiency-I in 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.290431","entity":"Foundayo (orforglipron)","event_type":"regulatory","id":"561a40a7-aeae-46b4-b1fe-70fad00ebdd9","impact":"high","pub_date":"2026-03-01","source_url":"https://www.drugs.com/newdrugs.html","summary":"FDA approved Foundayo (orforglipron) for weight loss in 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.290424","entity":"Eli Lilly","event_type":"regulatory","id":"4bf65928-5669-4e29-b00d-cf7c4d399481","impact":"high","pub_date":"2026-03-01","source_url":"https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQH3Vzu7dIG5Z8I__BCUcnFA7VRdtEebvf48OYvlniJfNGCaMGPnFLkkrLKFA-hEhD8nWNaqH_YwU5Jo6OiasR0kxJBMKkLzSXAQ2pEBC40SEqnxLk-VPeoDysvy3EodhWFZpWrYmEf9ZKncZZhSk8I59M_8OMX5D3ugzCUUR1p1SrhausaxN_vfl5zsa90n4lcT2vLDKCTaLpaLaa032mvS-SJ-UMGVRQt6QMpMUTMeZL2gZUaho6lH76cDhS_3g==","summary":"FDA approved Eli Lilly's Foundayo (orforglipron) for weight management under the National Priority Voucher program."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.290418","entity":"leucovorin","event_type":"regulatory","id":"31e07b93-b2bb-4ac2-b480-3d742eb55500","impact":"medium","pub_date":"2026-03-01","source_url":"https://www.neurologylive.com/view/fda-action-update-march-2026-lift-on-crl-expanded-approvals-and-priority-review","summary":"FDA approved expanded use of leucovorin for cerebral folate transport deficiency in March 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.290410","entity":"tividenofusp alfa","event_type":"regulatory","id":"3747ebc0-0cd1-42ff-b527-67996bf7f13e","impact":"high","pub_date":"2026-03-01","source_url":"https://www.neurologylive.com/view/fda-action-update-march-2026-lift-on-crl-expanded-approvals-and-priority-review","summary":"FDA granted accelerated approval to tividenofusp alfa for Hunter syndrome in March 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.290402","entity":"Ionis Pharmaceuticals","event_type":"regulatory","id":"0e37374d-a5df-4363-97ed-34709239a49b","impact":"high","pub_date":"2026-03-01","source_url":"https://www.neurologylive.com/view/fda-action-update-march-2026-lift-on-crl-expanded-approvals-and-priority-review","summary":"FDA accepted Ionis Pharmaceuticals' zilganersen NDA for priority review in Alexander disease in March 2026."},{"ai_confidence":0.98,"created_at":"2026-04-05T04:04:37.290371","entity":"Capricor","event_type":"regulatory","id":"52eaabf0-d283-435d-b433-c60e347a43cc","impact":"medium","pub_date":"2026-03-01","source_url":"https://www.neurologylive.com/view/fda-action-update-march-2026-lift-on-crl-expanded-approvals-and-priority-review","summary":"FDA lifted a complete response letter (CRL) for Capricor's deramiocel in March 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T04:04:37.290347","entity":"FORE Biotherapeutics","event_type":"regulatory","id":"aebd6212-1f6d-4d30-8903-19e17dddea37","impact":"high","pub_date":"2026-03-01","source_url":"https://fore.bio/fore-biotherapeutics-receives-breakthrough-therapy-designation-for-plixorafenib/","summary":"FDA granted Breakthrough Therapy Designation to FORE Biotherapeutics' plixorafenib for BRAF V600E-mutated high-grade glioma."},{"ai_confidence":0.95,"created_at":"2026-04-05T02:58:34.021685","entity":"Praxis Precision Medicines","event_type":"regulatory","id":"c0569807-2a03-4085-81c8-d418e390f8d5","impact":"medium","pub_date":"2026-04-01","source_url":"https://stocktitan.com/news/PRAX/praxis-precision-medicines-announces-fda-acceptance-and-priority-review-of-v2242131234.html","summary":"Praxis Precision Medicines announced FDA acceptance and Priority Review of its NDA for relutrigine for SCN2A and SCN8A DEEs, with a PDUFA date of September 27, 2026."},{"ai_confidence":0.85,"created_at":"2026-04-05T02:58:34.021679","entity":"FDA","event_type":"announcement","id":"bdfe305c-3c7f-492c-b864-10d32070b00d","impact":"low","pub_date":"2026-04-01","source_url":"https://www.biopharmadive.com/news/fda-turbulent-year-drugmakers-guessing-direction/712000/","summary":"Amidst a turbulent year, the FDA is emphasizing efforts to speed up drug approvals through programs like the national priority voucher."},{"ai_confidence":0.95,"created_at":"2026-04-05T02:58:34.021672","entity":"Cogent Biosciences","event_type":"regulatory","id":"57c4da46-b1b6-43a5-9ef6-988565fb0e84","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.globenewswire.com/news-release/2026/04/01/3820000/0/en/Cogent-Biosciences-Announces-Submission-of-New-Drug-Application-for-Bezuclastinib-in-Gastrointestinal-Stromal-Tumors-GIST.html","summary":"Cogent Biosciences submitted an NDA for bezuclastinib for Gastrointestinal Stromal Tumors (GIST) under the FDA's Real-Time Oncology Review program."},{"ai_confidence":0.95,"created_at":"2026-04-05T02:58:34.021665","entity":"BridgeBio Pharma","event_type":"regulatory","id":"84dc9236-0939-47c1-9d79-5de34a42bc5f","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.neurologylive.com/view/bridgebio-submits-nda-bbp-418-lgmd2i-r9-first-approved-therapy-limb-girdle-muscular-dystrophy","summary":"BridgeBio Pharma submitted an NDA to the FDA for BBP-418 for limb-girdle muscular dystrophy type 2I/R9, potentially the first therapy for any form of LGMD."},{"ai_confidence":0.9,"created_at":"2026-04-05T02:58:34.021658","entity":"FDA","event_type":"announcement","id":"8deac398-c3c4-450a-83b4-b82eacd44d10","impact":"low","pub_date":"2026-04-01","source_url":"https://www.medpagetoday.com/publichealthpolicy/fdageneral/109345","summary":"FDA Commissioner Marty Makary announced the agency's commitment to speeding up drug approvals and increasing over-the-counter medication availability."},{"ai_confidence":0.95,"created_at":"2026-04-05T02:58:34.021650","entity":"Egetis Therapeutics","event_type":"regulatory","id":"d7881036-8d1b-4584-8689-ca1044b5ccdb","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.biospace.com/article/egetis-announces-fda-acceptance-and-priority-review-of-nda-for-emcitate-r-tiratricol-for-mct8-deficiency/","summary":"Egetis Therapeutics announced FDA acceptance and Priority Review of its NDA for Emcitate (tiratricol) for MCT8 deficiency, with a PDUFA date of September 28, 2026."},{"ai_confidence":0.95,"created_at":"2026-04-05T02:58:34.021643","entity":"Fore Biotherapeutics","event_type":"regulatory","id":"5dc842a2-1f78-4759-b058-d37bd88e3fb6","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.targetedonc.com/view/fda-grants-breakthrough-therapy-designation-to-plixorafenib-for-braf-v600e-glioma","summary":"FDA granted Breakthrough Therapy Designation to Fore Biotherapeutics' plixorafenib for adult patients with BRAF V600E\u2013mutated high-grade glioma."},{"ai_confidence":0.95,"created_at":"2026-04-05T02:58:34.021636","entity":"Bristol Myers Squibb","event_type":"regulatory","id":"495bc1b7-0b56-49c0-a21c-6a17bca68dcf","impact":"medium","pub_date":"2026-04-01","source_url":"https://www.soho.com/news/fda-accepts-nda-for-iberdomide-in-relapsed-refractory-myeloma","summary":"FDA accepted Bristol Myers Squibb's NDA for iberdomide for relapsed/refractory multiple myeloma, granting Breakthrough Therapy Designation and Priority Review."},{"ai_confidence":0.85,"created_at":"2026-04-05T02:58:34.021628","entity":"Eli Lilly","event_type":"regulatory","id":"3cf44135-e932-49c7-b91f-50ec20c54073","impact":"medium","pub_date":"2026-03-31","source_url":"https://www.biospace.com/article/6-fda-decisions-to-watch-in-q2-2026/","summary":"Eli Lilly's orforglipron received a Commissioner's National Priority Voucher, expediting its review process prior to its approval."},{"ai_confidence":0.95,"created_at":"2026-04-05T02:58:34.021618","entity":"Orchard Therapeutics","event_type":"regulatory","id":"d316acc4-3b0c-45ff-9210-7b97d9888004","impact":"high","pub_date":"2026-03-27","source_url":"https://www.drugs.com/new-drug-approvals/2026.html","summary":"FDA granted accelerated approval to Orchard Therapeutics' Kresladi (marnetegragene autotemcel) for severe Leukocyte Adhesion Deficiency-I."},{"ai_confidence":1.0,"created_at":"2026-04-05T02:58:34.021474","entity":"Eli Lilly","event_type":"regulatory","id":"8d9238ec-0215-43a4-abf2-90a12a126a3a","impact":"high","pub_date":"2026-04-01","source_url":"https://www.fda.gov/newsroom/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program","summary":"FDA approved Eli Lilly's Foundayo (orforglipron) for obesity and weight-related conditions in a record 50 days under a priority voucher program."},{"ai_confidence":0.9,"created_at":"2026-04-05T02:58:34.021359","entity":"FDA","event_type":"regulatory","id":"45d72f78-5ffe-4bbb-b811-7f573bf22b9a","impact":"medium","pub_date":"2026-03-01","source_url":"https://www.pharmacytimes.com/view/fda-action-update-march-2026-lift-on-crl-expanded-approvals-and-priority-review","summary":"FDA approved expanded use of leucovorin calcium tablets for cerebral folate transport deficiency, marking the first therapy for this rare condition."},{"ai_confidence":0.95,"created_at":"2026-04-05T02:58:34.021311","entity":"Ionis Pharmaceuticals","event_type":"regulatory","id":"d04cd17e-de5e-4122-bce7-c36f0e10deff","impact":"medium","pub_date":"2026-03-01","source_url":"https://www.pharmacytimes.com/view/fda-action-update-march-2026-lift-on-crl-expanded-approvals-and-priority-review","summary":"FDA accepted Ionis Pharmaceuticals' NDA for zilganersen for Alexander disease with priority review, setting a PDUFA date of September 22, 2026."}]