fda compounding glp-1 warning letters october 2025 CDER Jump 50% in FY — What That Means for Industry FDA Sends 30 Warning Letters

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iodixanol and OptiPrep are used synonymously, which is incorrect (OptiPrep is the commercial name for a solution of 60% (w/v) iodixanol)

BPC-157 rebuilds the vascular and structural framework

There are three GLP-1 FDA decisions expected in early-mid 2026 Eli Lillys Mounjaro with a new indication to reduce the risk of major adverse cardiovascular events (MACE) in patients with T2DM Eli Lillys oral once-daily orforglipron for weight loss Novo Nordisks higher dose (7.2 mg) injectable once-weekly Wegovy for weight loss Given the considerable continued growth expected in the GLP-1 pipeline, Prime Therapeutics talented team of clinical experts actively monitors this emerging landscape

Furthermore, the agency clarified that compounded drugs are not the same as generic drugs, which are FDA-approved

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