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Markey legislation to strengthen federal oversight of compounding pharmacies
Congressman Edward J. Markey (D-Mass.) plans to introduce legislation that he believes will strengthen FDA's authority to oversee compounding pharmacies. The New England Compounding Center, located in Rep. Markey's congressional district, is the source of contaminated injectable steroids that led to a national meningitis outbreak, claiming 28 lives and sickening more than 300 people in 19 states, according to a press statement from Markey's office.
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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