New Drug Application

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Biotech

FDA shares more than 200 CRLs for now-approved drugs

All of the CRLs shared today are for drugs that have since gained approval from the agency, an HHS spokesperson told Fierce.
Gabrielle Masson Jul 10, 2025 10:54am
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FDA hopes AI can deliver 'rapid or instant' reviews

Jun 11, 2025 12:45pm
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FDA misses PDUFA date for Stealth’s ultra-rare disease candidate

Apr 30, 2025 9:00am
cancer target detection radiopharma radio

Corcept's phase 3 cancer win sends stock skyrocketing 85%

Mar 31, 2025 10:25am
black and white art of eyes

2 eye disease biotechs merge, set sights on FDA approval

Dec 12, 2024 11:05am
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Elevar offers $500M biobucks for Relay's rare cancer asset

Dec 3, 2024 3:04pm