PeptideSorted newshttps://peptidesorted.com/news/FDA actions, trial results and price changes for peptides and GLP-1 drugs, each linked to its primary source.en-usHHS says it will not act against compounding of six peptides, with conditionshttps://peptidesorted.com/news/2026-10-28-hhs-enforcement-discretion-peptide-compounding/https://peptidesorted.com/news/2026-10-28-hhs-enforcement-discretion-peptide-compounding/Wed, 28 Oct 2026 00:00:00 GMTHHS will not act against 503A compounding of BPC-157, TB-500, MOTS-c, KPV, epitalon and semax under ten conditions. None is FDA-approved.NSW Health reports a sharp rise in emergency visits linked to unapproved peptides, mostly retatrutidehttps://peptidesorted.com/news/2026-10-19-nsw-health-peptide-emergency-presentations/https://peptidesorted.com/news/2026-10-19-nsw-health-peptide-emergency-presentations/Mon, 19 Oct 2026 00:00:00 GMTNSW Health counted 1,180 emergency visits mentioning unapproved peptides from July 2025 to September 2026, mostly retatrutide. About 18% led to admission.FDA sends an interim policy on compounding certain peptides to White House reviewhttps://peptidesorted.com/news/2026-10-14-fda-interim-peptide-policy-sent-to-omb/https://peptidesorted.com/news/2026-10-14-fda-interim-peptide-policy-sent-to-omb/Wed, 14 Oct 2026 00:00:00 GMTAn FDA notice on compounding certain peptides reached White House review on October 14, 2026. HHS issued it on October 28 as an enforcement policy.First retatrutide phase 3 results published in NEJM and The Lancethttps://peptidesorted.com/news/2026-09-29-retatrutide-phase-3-results-published/https://peptidesorted.com/news/2026-09-29-retatrutide-phase-3-results-published/Tue, 29 Sep 2026 00:00:00 GMTTRIUMPH-1 (NEJM) and TRIUMPH-2 (Lancet) are the first peer-reviewed phase 3 results. Weight loss on 12 mg was 25.0% and 18.8% at 80 weeks.Novo Nordisk expects an FDA decision on CagriSema in the fourth quarter of 2026https://peptidesorted.com/news/2026-09-21-cagrisema-fda-decision-expected-q4/https://peptidesorted.com/news/2026-09-21-cagrisema-fda-decision-expected-q4/Mon, 21 Sep 2026 00:00:00 GMTNovo Nordisk expects an FDA decision on CagriSema, its cagrilintide and semaglutide combination for weight management, in Q4 2026. It is not yet approved.FDA warns online sellers of research-use-only GLP-1 and peptide productshttps://peptidesorted.com/news/2026-08-24-fda-warning-letters-research-peptide-sellers/https://peptidesorted.com/news/2026-08-24-fda-warning-letters-research-peptide-sellers/Mon, 24 Aug 2026 00:00:00 GMTFDA letters dated August 24, 2026 told online sellers that research-only semaglutide, tirzepatide, retatrutide and tesamorelin are unapproved new drugs.FDA advisory committee recommends six peptides, including BPC-157, for the 503A bulks listhttps://peptidesorted.com/news/2026-07-24-fda-advisers-vote-on-peptides-for-compounding/https://peptidesorted.com/news/2026-07-24-fda-advisers-vote-on-peptides-for-compounding/Fri, 24 Jul 2026 00:00:00 GMTFDA advisers voted July 23-24, 2026 to recommend BPC-157, KPV, TB-500, MOTS-c, Semax and epitalon for the 503A bulks list, against FDA staff advice.Retatrutide succeeds in two more phase 3 trials; Lilly plans FDA submission in early 2027https://peptidesorted.com/news/2026-07-23-retatrutide-triumph-2-3-and-filing-plan/https://peptidesorted.com/news/2026-07-23-retatrutide-triumph-2-3-and-filing-plan/Thu, 23 Jul 2026 00:00:00 GMTLilly reported topline TRIUMPH-2 (type 2 diabetes) and TRIUMPH-3 (heart disease) results for retatrutide and plans to file with the FDA in Q1 2027.Medicare GLP-1 Bridge begins: $50 a month for certain weight-loss drugshttps://peptidesorted.com/news/2026-07-01-medicare-glp1-bridge-launches/https://peptidesorted.com/news/2026-07-01-medicare-glp1-bridge-launches/Wed, 01 Jul 2026 00:00:00 GMTFrom July 1, 2026 through December 31, 2027, eligible Medicare Part D enrollees can get certain GLP-1 weight-loss drugs for $50 a month under a CMS pilot.FDA proposes keeping semaglutide, tirzepatide and liraglutide off the 503B bulks listhttps://peptidesorted.com/news/2026-04-30-fda-proposes-excluding-glp1s-from-503b-list/https://peptidesorted.com/news/2026-04-30-fda-proposes-excluding-glp1s-from-503b-list/Thu, 30 Apr 2026 00:00:00 GMTFDA proposed leaving semaglutide, tirzepatide and liraglutide off the 503B bulks list, finding no clinical need for outsourcing facilities to make them.FDA approves Foundayo (orforglipron), a once-daily GLP-1 pill for weight managementhttps://peptidesorted.com/news/2026-04-01-fda-approves-foundayo-orforglipron/https://peptidesorted.com/news/2026-04-01-fda-approves-foundayo-orforglipron/Wed, 01 Apr 2026 00:00:00 GMTThe FDA approved Foundayo (orforglipron), a daily pill for chronic weight management in adults. It is a small-molecule GLP-1 with no empty-stomach rule.