PDUFA

red tape delay stop error tie down stall
Biotech

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

An approval decision for Stealth’s ultra-rare disease candidate has been delayed—again. This time, the FDA hasn't set a new date.
Gabrielle Masson 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
journey path light sunshine stairs climb reach

Karuna's schizophrenia drug set for FDA decision in Q3 2024

Nov 29, 2023 10:00am
valneva

FDA delays decision on Valneva's chikungunya vaccine by 3 months

Aug 14, 2023 6:00am