PDUFA

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Biotech

FDA delays approval verdict for Exelixis-Tecentriq combo

The three-month delay in the review period was coupled with the FDA asking for updated safety and efficacy data by March 2027.

Marissa Russo Sep 11, 2026 9:52am

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Praxis faces FDA delay, analysts point finger at agency layoffs

Jun 30, 2026 4:13am

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