FDA delay

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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

delay

FDA delays decision on Merus' first-in-class cancer drug

Nov 5, 2024 9:14am

red tape pause delay countdown FDA cancel stop

FDA demands data on 2 PTC candidates, delaying filing

Oct 27, 2023 7:30am

calendar hour glass wait delay months

FDA resource constraints delay decision on Iovance cell therapy

Sep 15, 2023 5:20am

valneva

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

Aug 14, 2023 6:00am

Daiichi Sanyko Kitamoto site

FDA again delays Daiichi challenge to Astellas, Novartis in AML

Apr 21, 2023 9:25am