Regulatory tracking for semaglutide and the broader GLP-1 / GIP class — telehealth-focused.
FDA approved Wegovy (semaglutide 2.4 mg) for cardiovascular risk reduction in adults with overweight/obesity and established cardiovascular disease, based on SELECT trial results showing 20% MACE reduction.
Novo Nordisk submitted FLOW trial data to support a kidney indication for semaglutide. FLOW (NEJM 2024, PMID 38785189) showed 24% reduction in major kidney/CV events in T2D + CKD patients.
FDA issued warning letters targeting compounders dispensing semaglutide sodium and semaglutide acetate salt forms. The agency emphasized that only the peptide base form is acceptable, and salt forms are unapproved active ingredients.
SELECT trial published in New England Journal of Medicine (PMID 37952131). Semaglutide 2.4 mg produced 20% reduction in MACE over a median 39.8 months in non-diabetic adults with overweight/obesity + established CVD.
Following Novo Nordisk supply expansion, FDA confirmed that semaglutide is no longer on the official drug shortage list, raising questions about ongoing 503A and 503B compounding eligibility under FDCA Section 503A and 503B.
FDA approved Wegovy (semaglutide 2.4 mg) for chronic weight management in adults with obesity (BMI ≥30) or overweight (BMI ≥27) with at least one weight-related comorbidity, based on the STEP trial program.