The FDA Has Accepted The Resubmission Of Rocket Pharmaceuticals' Marketing Application For Kresladi (Marnetegragene Autotemcel; Marne-cel), An Investigational Gene Therapy For Severe Leukocyte Adhesion Deficiency-I. PDUFA Date Is March 28, 2026
Benzinga Newsdesk 1 year ago
BiotechNewsHealth CareFDAGeneral
Prescription Drug User Fee Act (PDUFA) target action date is March 28, 2026All primary and secondary endpoints were met, and KRESLADI was well toleratedRocket is eligible for a Rare Pediatric Disease Priority Review
- Prescription Drug User Fee Act (PDUFA) target action date is March 28, 2026
- All primary and secondary endpoints were met, and KRESLADI was well tolerated
- Rocket is eligible for a Rare Pediatric Disease Priority Review Voucher, should KRESLADI be approved