Vinay Prasad

Makary
Biotech

FDA unveils new pathway to speed custom gene editing therapies

Called the “plausible mechanism pathway,” the program is designed to offer a new way to market for personalized therapies, FDA officials said.
Angus Liu Nov 12, 2025 5:00pm
uturn

uniQure's gene therapy for Huntington's hits FDA roadblock

Nov 3, 2025 10:03am
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After 'complete standstill,' biotech market reaches new normal

Aug 20, 2025 11:04am
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Regenxbio's Hunter gene therapy latest to face FDA delay

Aug 19, 2025 10:30am
FDA
Favicon Fierce Pharma

Vinay Prasad is back at the FDA after last month's surprise ouster

Aug 9, 2025 12:22pm
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Prasad exit signals more permissive FDA for cell and gene field

Jul 31, 2025 9:10am