PDUFA Delay: FDA Asks for More Information From Abeona for Pz-cel Market Application
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to Abeona’s Biologics License Application (BLA) for pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB). In the letter, the FDA noted that certain additional information needed to satisfy Chemistry Manufacturing and Controls (CMC) requirements must […]