FDA delay

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Biotech

Regenxbio's Hunter gene therapy latest to face FDA delay

The review extension and request for more data bears the fingerprints of recently returned CBER head Vinay Prasad, M.D.
Darren Incorvaia Aug 19, 2025 10:30am
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Another biotech hit with FDA delay for ALS asset

Aug 18, 2025 11:01am
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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
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FDA demands data on 2 PTC candidates, delaying filing

Oct 27, 2023 7:30am