News

FDA announcements

• 2026-04-30 FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List The FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list, stating there is no clinical need for outsourcing facilities to compound these drugs from bulk substances. The agency is accepting public comments until June 29, 2026, before making a final decision. Read more →
• 2026-03-19 FDA Approves Fourth Product Under National Priority Voucher Program, Higher Dose Semaglutide The FDA approved a higher 7.2 mg dose of Wegovy (semaglutide), called Wegovy HD, for weight loss and long-term maintenance in adults with obesity or overweight with weight-related conditions, granting the approval under the National Priority Voucher program in 54 days. Clinical data showed the higher dose led to greater weight reduction with a similar safety profile to lower doses, though gastrointestinal side effects and skin sensations were more common. The approval includes a boxed warning about thyroid C-cell tumor risk and is part of the FDA's effort to expedite therapies addressing critical health priorities. Read more →
• 2026-03-03 FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s The FDA issued 30 warning letters to telehealth companies for falsely or misleadingly marketing compounded GLP-1 drugs, claiming they are equivalent to FDA-approved products. The agency emphasized that compounded drugs are not FDA-reviewed for safety or effectiveness and are not the same as generics, while continuing its broader crackdown on deceptive pharmaceutical advertising. Read more →
• 2026-02-06 FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs The FDA announced plans to restrict non-FDA-approved GLP-1 active pharmaceutical ingredients used in compounded drugs marketed by companies like Hims & Hers, citing concerns over unverified quality, safety, and efficacy. The agency also warned against misleading claims in advertising, stating that compounded products cannot be presented as generics or clinically proven alternatives to FDA-approved drugs. Read more →