FDA has granted fast-track designation for the development of AVI-7288 and AVI-7537 (Sarepta Therapeutics), for the treatment of Marburg virus and Ebola virus, respectively.
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.