Alvimopan (Entereg, Adolor/GlaxoSmithKline) for the treatment of postoperative ileus.
Approvable designations
Priority review
Fast-track designations
Orphan drug designations
Non-approvable 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.