What changed this cycle.
Dated briefs on FDA actions, clinical readouts, and market shifts that affect how GLP-1 access actually works.
FDA 503B Bulks List comment period closes on GLP-1 exclusion proposal
The public comment window on FDA's April 30 proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List closed today. The 503A patient-specific pathway is unaffected.
FDA issues warning letters to 30 telehealth companies over compounded GLP-1 marketing
The agency cited misleading direct-to-consumer marketing, including claims about FDA approval, comparable efficacy to brand-name products, and undisclosed pharmacy sourcing.
Hims & Hers partners with Novo Nordisk, winds down compounded GLP-1 marketing
Hims announced a distribution partnership with Novo Nordisk for brand-name semaglutide and is sunsetting its compounded GLP-1 program for new patients.
FDA approves tirzepatide for obstructive sleep apnea in adults with obesity
Zepbound becomes the first medication ever approved for OSA, based on the SURMOUNT-OSA trials showing 25–29 events/hour reduction in AHI.
SELECT trial: semaglutide cuts MACE by 20% in non-diabetic CVD patients
Landmark trial of 17,604 adults establishes that semaglutide 2.4 mg reduces cardiovascular events in overweight/obese patients with established CVD, independent of glycemic status.
GLP Review rubric updated to v3.0
We've updated our six-pillar transparency rubric to v3.0, raising the per-pillar pass threshold to 70% and adding sub-criteria for cold-chain shipping and CoA-on-request.
FDA expands Wegovy label to include cardiovascular risk reduction
Based on SELECT, Wegovy becomes the first weight-loss medication with a cardiovascular risk reduction indication.
FDA removes semaglutide from Drug Shortages list
The 2022–2024 semaglutide shortage that fueled the compounded-GLP-1 market is officially over per FDA. Compounding rules tighten.
FDA removes tirzepatide from Drug Shortages list
Tirzepatide is delisted ahead of semaglutide. Eli Lilly cites resolved manufacturing capacity.
Eli Lilly expands LillyDirect cash-pay pricing for tirzepatide
Lilly's direct-to-consumer LillyDirect channel adds reduced cash-pay pricing for tirzepatide single-dose vials.
Retatrutide phase-3 readouts: triple agonist shows >22% mean weight loss
Eli Lilly's investigational triple-agonist retatrutide produced 22–24% mean weight loss in phase-3 obesity trials. FDA submission expected late 2026.
Federal court denies preliminary injunction in compounded-tirzepatide case
A federal district court denied a preliminary injunction sought by a coalition of compounding pharmacies to reverse FDA's tirzepatide Shortages-list delisting.
NexLife launches Care360 coaching layer alongside expanded clinician network
The 2026 #1-ranked provider adds longitudinal coaching and expanded clinician availability across all 50 states.
FDA proposes excluding GLP-1s from the 503B Bulks List
Notice published in the Federal Register on April 30 proposes excluding semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. 60-day comment window opens.
Five years after STEP-1: the GLP-1 obesity era, in numbers
On the five-year anniversary of STEP-1's NEJM publication, a perspective piece looks at how the field has evolved.