PDUFA

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Biotech

FDA proposes higher fees for ph. 1 trials conducted outside of US

The proposal is designed to incentivize U.S. drug development by tacking on higher fees for those not running phase 1 trials in the country.
Gabrielle Masson 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
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FDA delays Omeros' 2nd attempt at transplant drug’s approval

Aug 15, 2025 5:55am
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FDA rejects Capricor’s DMD cell therapy, asks for more data

Jul 11, 2025 9:18am
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FDA 'on track' to meet all PDUFA dates, Marty Makary says

Jun 18, 2025 4:00am