PDUFA

delay
Biotech

Praxis faces FDA delay, analysts point finger at agency layoffs

TD Cowen analysts said they “strongly believe FDA bandwidth constraints from last year’s agency downsizing likely contributed to the delay.”
Nick Paul Taylor Jun 30, 2026 4:13am
AZ

FDA delays ruling on AstraZeneca drug after negative adcomm vote

May 27, 2026 4:43am
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Aldeyra dry eye disease decision hit by FDA delay

Dec 16, 2025 11:55am
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FDA proposes higher fees for ph. 1 trials conducted outside of US

Dec 3, 2025 5:19pm
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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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Regenxbio's Hunter gene therapy latest to face FDA delay

Aug 19, 2025 10:30am