Two recalled products manufactured by the New England Compounding Center (NECC), Farmingham, Mass., have tested positive for bacterial contamination, according to an FDA update.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.