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FDA launches new priority review voucher program for select biopharmas

U.S. FDA

China
Biotech

China proposal would match US clinical trial review times

If implemented, the new review timeline would match the FDA’s 30-day period.
Angus Liu Jun 16, 2025 5:30pm
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Favicon Fierce Pharma

2nd patient dies after Sarepta's DMD gene therapy Elevidys

Jun 16, 2025 10:58am
Warning Letter FDA Warning Letter FDA

FDA chides Applied Therapeutics' trial conduct in warning letter

Dec 4, 2024 11:21am
Image of a neon sign with the word no lit up next to an unlit yes

Lykos' MDMA treatment for PTSD has been quashed at the FDA

Aug 10, 2024 9:07am
Richard Pazdur

FDA's Richard Pazdur explains confirmatory trial rejection, more

Apr 8, 2024 6:00am
Marks

Peter Marks says FDA ready to review novel cancer vaccines

Apr 3, 2024 2:39pm

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