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FDA delay
Biotech
FDA delays decision on Ascendis' dwarfism prospect by 3 months
The FDA pushed back the decision deadline by three months to buy time to review recently submitted information.
Nick Paul Taylor
Nov 26, 2025 9:45am
Denali's Hunter syndrome drug latest to be hit by FDA delay
Oct 14, 2025 8:09am
After delay, Coya receives FDA go-ahead for phase 2 ALS trial
Aug 25, 2025 11:04am
Regenxbio's Hunter gene therapy latest to face FDA delay
Aug 19, 2025 10:30am
Another biotech hit with FDA delay for ALS asset
Aug 18, 2025 11:01am
FDA delays decision on Biohaven troriluzole filing, plans adcomm
May 15, 2025 6:02am