BioCentury
DATA GRAPHICS | Data Byte

Rocket gene therapy, among FDA’s March approvals, earns PRV

Last month’s approvals also include four NMEs

April 3, 2026 10:58 PM UTC

FDA approved Rocket’s Kresladi to treat leukocyte adhesion deficiency type I on March 26. The gene therapy delivering MAC-1 appears to be the first BLA to successfully pass CBER this year. 

Rocket Pharmaceuticals Inc. (NASDAQ:RCKT) said Kresladi marnetegragene autotemcel (marne-cel), its first product, will launch by year-end. FDA issued a rare pediatric disease priority review voucher with the approval...