Patients with nonvalvular atrial fibrillation (NVAF) who also have diabetes experienced similar safety and efficacy with dabigatran etexilate mesylate (Pradaxa) 150 mg or dabigatran 110 mg relative to warfarin, in comparison to patients without diabetes who have NVAF, according to data presented at American Heart Association's Scientific Sessions 2012.
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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