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As of June 2026, the FDA is in a public comment period on a proposal to formally exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulk Drug Substances List
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Meta-analyses have confirmed the benefit of GLP-1 RAs as a class in both secondary and primary prevention of cardiovascular disease, and in reduction of adverse kidney outcomes in people with T2D (Kristiensen et al, 2019
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Mok J, Adeleke MO, Brown A, et al
