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An FDA decision on depemokimab is expected in mid-December
FDAs Concerns with Unapproved GLP-1 Drugs Used for Weight Loss Compounding and the FDA: Questions and Answers Understanding unapproved versions of these drugs FDA is aware that some patients and health care professionals may look to unapproved versions of GLP-1 (glucagon-like peptide-1 (GLP-1) receptor agonists) drugs, including semaglutide and tirzepatide, as an option for weight loss
Furthermore, manufacturing complexities associated with peptide synthesis and cold-chain logistics increase production and distribution costs