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Semaglutide news

Regulator decisions, trial results and approvals involving Semaglutide, newest first. Each report is dated and cites the official record.

  1. FDA warns sellers of semaglutide, tirzepatide and retatrutide labelled "for research purposes"

    FDA has sent warning letters to online companies selling semaglutide, tirzepatide and retatrutide with "research use only" labels, most recently on 24 August 2026. In each letter FDA said the labels did not stop the products being unapproved new drugs, because the sellers' own websites showed they were meant for human use. Retatrutide remains unapproved.

  2. FDA proposes keeping semaglutide, tirzepatide and liraglutide off the 503B bulks list

    On 30 April 2026 FDA proposed not to add semaglutide, tirzepatide or liraglutide to the 503B bulks list, saying it found no clinical need for outsourcing facilities to compound them from bulk ingredients. The comment period was later extended to 30 July 2026. As of 24 September 2026 we have found no final decision.

  3. FDA approves Wegovy tablets, the first oral semaglutide for weight management

    On 22 December 2025 the FDA approved Wegovy tablets (NDA 218316), a once-daily oral form of semaglutide for chronic weight management. The approval rests mainly on the OASIS 4 trial, in which a 25 mg daily tablet produced an average weight loss of 13.6% at 64 weeks against 2.2% on placebo. It is the first semaglutide tablet licensed in the US for weight rather than type 2 diabetes.

  4. SURMOUNT-5: tirzepatide beat semaglutide for weight loss in the first head-to-head obesity trial

    SURMOUNT-5, published online in the New England Journal of Medicine on 11 May 2025, compared weekly tirzepatide with weekly semaglutide in 751 adults with obesity but without diabetes. After 72 weeks, average weight loss was 20.2% with tirzepatide and 13.7% with semaglutide. It is the first randomised trial to compare the two drugs directly for obesity.