First-time generic approvals: rivastigmine capsules
Rivastigmine capsules, 1.5, 3, 4.5, and 6 mg base (equiv to Exelon capsules)
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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.