Recent FDA action (through August 2009) related to trazodone, casopitant, sertindole, alogliptin, bepotastine, trabectedin, and velaglucerase alfa
Complete response
Recommended for approval
Not recommended for approval
Priority review
Orphan drug designation
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.