FDA has approved cysteamine ophthalmic solution (Cystaran, Sigma-Tau Pharmaceuticals) 0.44%, a topical ophthalmic therapeutic, developed in partnership with the National Institutes of Health (NIH), for the treatment of corneal cystine crystal accumulation in patients with cystinosis.
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.