[{"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."}]