FDA & Regulation
Breaking news and analysis on FDA actions, drug approvals, compounding regulations, and enforcement affecting GLP-1 medications.
Breaking
FDA Approves First Oral GLP-1 for Weight Loss, Ending the Injection-Only Era
Eli Lilly's orforglipron (Foundayo) becomes the first daily pill approved for obesity at $149/month, a seismic shift for 40 million Americans on injectable GLP-1 medications.
Enforcement
FDA Issues 30 Warning Letters in Largest-Ever Crackdown on Compounded GLP-1 Sellers
The FDA declared semaglutide and tirzepatide shortages resolved, then moved against telehealth companies still marketing compounded versions illegally.
State Regulation
States Move to Ban Compounded Semaglutide as FDA Enforcement Widens
At least six states have introduced legislation restricting 503A compounding pharmacies from producing GLP-1 receptor agonists.
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