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Ameridose voluntarily recalls products
Ameridose, LLC, is voluntarily recalling all of its unexpired products in circulation, according to an FDA press release Oct. 31. Ameridose, based in Westborough, Mass., is managed by the same parties that manage the New England Compounding Center (NECC), of Framingham, Mass. Injectable drugs produced by NECC are linked to the fungal meningitis outbreak, which has resulted in 377 fungal meningitis cases, 9 cases of peripheral joint infections and 29 deaths.
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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