FDA-related information through December 2007 on Guaifenesin/codeine extended-release, delayed-release valproic acid, telavancin, Endeavor, oral beclomethasone, and R7128
Approvable designations
Recommendation for approval
Nonapprovable designation
Orphan drug designations
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.