FDA delay

delay FDA delay

Biotech

FDA delays decision on Biohaven troriluzole filing, plans adcomm

Forty-eight hours after saying its filing was on track, the biopharma revealed the FDA has delayed a decision on its rare disease drug troriluzole.

Nick Paul Taylor May 15, 2025 6:02am

red tape delay stop error tie down stall

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

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