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Details illuminate start of fungal meningitis outbreak
Investigators from the Tennessee Department of Health and the Centers for Disease Control and Prevention (CDC) provided an aggressive public health response following a single case of Aspergillus fumigatus meningitis in an immunocompetent adult who had received an epidural injection of preservative-free methylprednisolone acetate at a clinic in Tennessee, according to a report published Nov. 7 in the New England Journal of Medicine.
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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