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New Drug Application
Biotech
FDA hopes AI can deliver 'rapid or instant' reviews
FDA leaders believe that AI can make a “first pass” at the nearly 500,000 pages of documents included in applications received by the agency.
Darren Incorvaia
Jun 11, 2025 12:45pm
FDA misses PDUFA date for Stealth’s ultra-rare disease candidate
Apr 30, 2025 9:00am
Corcept's phase 3 cancer win sends stock skyrocketing 85%
Mar 31, 2025 10:25am
2 eye disease biotechs merge, set sights on FDA approval
Dec 12, 2024 11:05am
Elevar offers $500M biobucks for Relay's rare cancer asset
Dec 3, 2024 3:04pm
Aldeyra preps for FDA refiling as dry eye drug hits ph. 3 goal
Aug 8, 2024 10:48am
