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FDA's Decision on Recessive Dystrophic Epidermolysis Bullosa Treatment Delayed

Prademagene zamikeracel is an autologous cell therapy that consists of epidermal sheets that deliver functional COL7A1 genes into the patient’s own skin cells to enable normal type VII collagen expression and facilitate wound healing. ....

Drug Administration , Complete Response Letter , Abeona Therapeutics , Biologics License Application , Chemistry Manufacturing , Vish Seshadri ,

Abeona Therapeutics (ABEO) Receives FDA Complete Response Letter on Pz-cel

Abeona Therapeutics (ABEO) Receives FDA Complete Response Letter on Pz-cel
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Drug Administration , Company Biologics License Application , Abeona Therapeutics Inc , Abeona Therapeutics , Complete Response Letter , Biologics License Application , Late Cycle Review Meeting , Chemistry Manufacturing , Vish Seshadri , Chief Executive Officer , Entry Code ,