U.S. FDA

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
FDA
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George Tidmarsh exits as LinkedIn post sparks lawsuit, probe

Nov 3, 2025 11:13am
uturn

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

Nov 3, 2025 10:03am
VanNaarden

Lilly oncology head weighs in on FDA cancer drug policies

Oct 21, 2025 11:53am
Graphic of a fork in the road with arrows pointing in either direction
Favicon Fierce Pharma

Prasad exit signals more permissive FDA for cell and gene field

Jul 31, 2025 9:10am
FDA
Favicon Fierce Pharma

Vinay Prasad departs FDA amid controversy over gene therapy

Jul 30, 2025 9:33am