FDA delay

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Biotech

Aldeyra dry eye disease decision hit by FDA delay

The delay comes after the regulator sent a draft label for the drug candidate to the company in early December and Aldeyra responded with comments.
Darren Incorvaia Dec 16, 2025 11:55am
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FDA delays decision on Ascendis' dwarfism prospect by 3 months

Nov 26, 2025 9:45am
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Denali's Hunter syndrome drug latest to be hit by FDA delay

Oct 14, 2025 8:09am
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After delay, Coya receives FDA go-ahead for phase 2 ALS trial

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