FDA Accepts Abeona’s BLA Resubmission of Pz-cel for Recessive Dystrophic Epidermolysis Bullosa; PDUFA Date Set
The U.S. Food and Drug Administration (FDA) has accepted Abeona’s resubmission of its Biologics License Application (BLA) for prademagene zamikeracel (pz-cel) for the treatment of recessive dystrophic epidermolysis bullosa. Pz-cel is an investigational autologous cell-based gene therapy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 29, 2025. […]