PDUFA

Clock in front of the subway
Biotech

FDA 'on track' to meet all PDUFA dates, Marty Makary says

All the figurative FDA trains are running on time, according to the agency’s leader Marty Makary, M.D.
Gabrielle Masson Jun 18, 2025 4:00am
FDA stop sign

FDA's 'heavy workload' blamed for delaying KalVista's PDUFA date

Jun 16, 2025 4:33am
red tape delay stop error tie down stall

FDA misses PDUFA date for Stealth’s ultra-rare disease candidate

Apr 30, 2025 9:00am
FDA stop sign

FDA delays decision on Stealth's ultrarare disease med

Jan 23, 2025 9:45am
Delayed on hold

FDA delays decision on Moderna's RSV shot until the end of May

May 10, 2024 10:30am
delay FDA delay

Applied Tx’s pediatric rare disease prosect hits another snag

Mar 29, 2024 10:21am