Desk
Approvals, label changes and agency decisions on peptide medicines.
12 stories · latest 7 Nov 2026
The REG desk files what medicines agencies decide about peptide drugs. That covers approvals and refusals, new or narrower labels, safety communications, shortage listings, compounding lists and the advisory votes that come before a decision.
Each story names the agency and the document it published, so a reader can check the wording at the source. Where an agency only recommends and another body decides, the story says which step has happened and which has not. Decisions differ by country; a US label change says nothing about Europe or Japan until their own agency acts.
A Pharmacy Times review says 13 state Medicaid programs covered GLP 1 drugs for obesity in January 2026, down from 16, while Medicare relies on a temporary Bridge through 2027. Heart and kidney benefits stay tied to specific drugs and trials.
WASHINGTON
A pharmacist's review says the HHS policy cites human studies and a test certificate for BPC 157 without releasing them. All six peptides were included against FDA reviewer advice, and comments close November 13.
WASHINGTON · HHS enforcement discretion policy with Appendix B, October 2026; Science-Based Medicine analysis by pharmacist Scott Gavura, 5 Nov 2026
The ASA ruled that two Voy ads and one each from Juniper and MedExpress promoted prescription only weight loss tablets to the public, even though none named oral Wegovy. The MHRA welcomed the rulings.
LONDON · ASA rulings published 4 Nov 2026, as reported by The Independent and Chemist and Druggist
An interim HHS policy lets licensed pharmacies compound BPC 157, epitalon, KPV, MOTS c, Semax and TB 500 under ten conditions. None is FDA approved, FDA reviewers advised against listing them, and a final rule is still pending.
WASHINGTON · HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, posted Oct 27 to 28, 2026
The FDA cleared insulin icodec for children aged 10 and older with type 2 diabetes, the first once weekly insulin for this group. The decision rests on adult trials and an 18 patient blood level study, not a pediatric efficacy trial.
SILVER SPRING, MD · FDA Drugs news item, 23 Oct 2026, with Novo Nordisk release of the same day
WADA left the status of GLP 1 drugs unchanged for 2027. Semaglutide and tirzepatide stay legal for athletes and on its Monitoring Program while two studies look at their effects in sport.
MONTREAL · WADA announcement of the 2027 Prohibited List (approved by the Executive Committee 10 Sep 2026), as republished by World Rugby, 6 Oct 2026
South Korea's health ministry will inspect hospitals and clinics suspected of selling self injected obesity drugs on site in breach of the rule that doctors prescribe and pharmacists dispense. Violations can bring prison terms, fines or licence suspensions.
SEJONG · Ministry of Health and Welfare press release, 22 Oct 2026, reported by Korea Biomedical Review
India's Subject Expert Committee asked Novo Nordisk for Indian absorption and clinical data and an account of SNAC levels before it advises on oral Wegovy. The same meeting cleared three Roche petrelintide trials.
NEW DELHI · CDSCO Subject Expert Committee (Endocrinology and Metabolism) recommendations, meeting of 23 Sep 2026, posted 19 Oct 2026
An oral version of Wegovy was approved in the US, making it the first tablet GLP-1 medicine for chronic weight management. Getting a peptide through the gut is the engineering story.
BAGSVÆRD, Denmark · Novo Nordisk announcement of FDA approval; OASIS 4 trial
Semaglutide became the second drug cleared in the US for MASH with moderate to advanced fibrosis, on the strength of liver biopsy results at 72 weeks.
SILVER SPRING, Md. · FDA approval; ESSENCE trial part 1 (NEJM, 2025)
Ozempic is now approved to reduce the risk of worsening kidney disease, kidney failure and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.
SILVER SPRING, Md. · FDA approval; FLOW trial (NEJM, 2024)
The agency extended the Zepbound label to moderate-to-severe obstructive sleep apnea in adults with obesity, the first approval of any drug for the condition.
SILVER SPRING, Md. · FDA announcement; SURMOUNT-OSA trials (NEJM, 2024)
