FDA delay

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Biotech

After delay, Coya receives FDA go-ahead for phase 2 ALS trial

The agency previously alerted Coya that it would miss the July 30 deadline for a decision on the IND application due to limited resources.
Darren Incorvaia Aug 25, 2025 11:04am
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Regenxbio's Hunter gene therapy latest to face FDA delay

Aug 19, 2025 10:30am
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Another biotech hit with FDA delay for ALS asset

Aug 18, 2025 11:01am
delay FDA delay

FDA delays decision on Biohaven troriluzole filing, plans adcomm

May 15, 2025 6:02am
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FDA misses PDUFA date for Stealth’s ultra-rare disease candidate

Apr 30, 2025 9:00am
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FDA delays decision on Merus' first-in-class cancer drug

Nov 5, 2024 9:14am