Abeona Therapeutics completes FDA Pre-License Inspection for pz-cel BLA manufacturing facility.

Abeona Therapeutics completes FDA Pre-License Inspection (PLI) for its manufacturing facility related to its Biologics License Application (BLA) for pz-cel for recessive dystrophic epidermolysis bullosa (RDEB). The FDA has also completed clinical study site inspections at Stanford University School of Medicine and the University of Massachusetts Medical School. The FDA's review of Abeona's pz-cel BLA is ongoing, with a target Prescription Drug User Fee Act (PDUFA) date of May 25, 2024.

March 18, 2024
4 Articles