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The FDA has proposed to bar 503B outsourcing facilities from bulk compounding semaglutide and tirzepatide. The shortage-list pathway already closed in 2024 and 2025; this proposal would remove the remaining bulks-list route.

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Efficacy, safety and cardiovascular outcomes of oncedaily oral semaglutide in patients with type 2 diabetes: The PIONEER programme - Thethi - 2020 - Diabetes, Obesity and Metabolism - Wiley Online Library

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