GLP-1 watch
GLP-1 news
Curated FDA approvals, manufacturer announcements, peer-reviewed trial results, and shortage / pricing changes for Wegovy, Ozempic, Mounjaro, Zepbound, and emerging GLP-1s. Every entry cites its primary source.
Editorial briefings
Approval · 2026-05-15
FDA approves Wegovy HD — higher-dose semaglutide for sustained weight loss
Novo Nordisk receives FDA approval for Wegovy HD (semaglutide 7.2 mg weekly). Phase-3 STEP-UP data shows ~20% weight loss at 68 weeks. Launch pricing matches existing Wegovy.
Litigation · 2026-05-22
MDL-3094 GLP-1 GI litigation: ~3,600 cases consolidated in EDPA before Judge Marston
Judge Karen S. Marston (EDPA) oversees the federal GLP-1 gastrointestinal-injury MDL. As of mid-2026, bellwether trial dates are not yet publicly scheduled; a Science Day was set for June 2, 2026. NAION (vision-loss) claims are consolidated separately as MDL-3163.
Guideline · 2026-05-28
NICE expands tirzepatide weight-management eligibility in England (TA1026 update)
National Institute for Health and Care Excellence (NICE) revised TA1026 May 2026, lowering the BMI threshold to ≥30 (from ≥35) for NHS-funded tirzepatide. ~250,000 additional UK adults newly eligible.
Approval · 2026-05-06
Foundayo (orforglipron) — first oral non-peptide GLP-1 — launches in US
Eli Lilly launched Foundayo (orforglipron 36 mg daily tablet) for chronic weight management on May 5, 2026. Phase-3 ATTAIN-1 showed ~12.4% mean weight loss. No empty-stomach or fast required.
Wire feed
- Policy
CMS adds Zepbound to Medicare Part D for obstructive sleep apnea
CMS guidance now classifies tirzepatide under the OSA indication for Medicare drug coverage, expanding access for an estimated 6.4M beneficiaries.
Read at CMS (opens in a new tab) - FDA
FDA expands Wegovy approval to adolescents 12+
Novo Nordisk receives FDA label update allowing Wegovy 2.4 mg in adolescents aged 12 and older with BMI ≥95th percentile.
Read at FDA (opens in a new tab) - Shortage
FDA confirms tirzepatide off the shortage list for the 6th consecutive month
Sustained supply triggers stricter compounding pharmacy enforcement — 503A and 503B pharmacies notified to discontinue tirzepatide production.
Read at FDA Drug Shortage Database (opens in a new tab) - Trial
STEP-UP trial: oral semaglutide 25 mg matches injectable for weight loss
NEJM publishes phase 3 results — 25 mg oral semaglutide produces 13.6% mean weight loss at 64 weeks vs 2.2% placebo.
Read at NEJM (opens in a new tab) - Manufacturer
LillyDirect drops self-pay Zepbound vial pricing to $399/mo
Eli Lilly cuts direct-to-consumer Zepbound vial pricing by $150/mo to compete with compounded semaglutide; covers 2.5, 5, 7.5 mg doses.
Read at Eli Lilly (opens in a new tab) - FDA
FDA approves orforglipron — first oral non-peptide GLP-1
Eli Lilly's orforglipron is the first oral small-molecule GLP-1 agonist; no fasting requirement, no SNAC absorption enhancer, conventional pill manufacturing.
Read at FDA (opens in a new tab)
Editorial policy: curated by our editorial team; every entry verified against the primary source (FDA press release, manufacturer announcement, peer-reviewed publication) before publication. Submission line: [email protected].