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FDA Issues CRL to Abeona for Potential RDEB Cell Therapy - Vimarsana News

FDA Issues CRL to Abeona for Potential RDEB Cell Therapy

Abeona's pz-cel is up for indicated use to treat patients with recessive dystrophic epidermolysis bullosa.

FDA Completes Bioresearch Monitoring Inspection of Pz-Cel for Recessive Dystrophic Epidermolysis Bullosa - Vimarsana News

FDA Completes Bioresearch Monitoring Inspection of Pz-Cel for Recessive Dystrophic Epidermolysis Bullosa

This announcement is part of the overall evaluation period for the treatment, as the PDUFA target action date for pz-cel remains May 2024.