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NABP with state boards create action plan to help enforce compounding regulations
Last week, NABP Executive Director Carmen Catizone, MS, RPh, unveiled an action plan to inspect nonresident compounding pharmacies and create a database to share regulatory information about these pharmacies with the state boards of pharmacy nationwide. This was in response to the fungal meningitis outbreak that took the lives of 37 individuals and injured 590.
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.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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