Regulatory
Coverage and analysis in regulatory from the Peptidings newsroom.
Medicare’s GLP-1 Bridge Starts July 1: $50 Copays, Three Drugs, and One Catch
Starting July 1, 2026, Medicare covers Wegovy, the Zepbound KwikPen, and Foundayo at $50 a month under the new Medicare GLP-1 Bridge. The fine print matters.
Medicare’s GLP-1 Bridge: $50/Month Copay for Wegovy, Zepbound, and Foundayo Starting July
Medicare GLP-1 Bridge launches July 1, 2026: $50/month copay for Wegovy, Zepbound KwikPen, and Foundayo through Dec 2027. The first program to breach the weight-loss-only coverage ban.
International GLP-1 Enforcement Converges: Connecticut, France, and the End of the Wild West
Connecticut AG settles with Made-in-China.com — first international e-commerce GLP-1 action. France fines Novo and Lilly €1.9M for indirect promotion. Enforcement converging.
Two Camps Form on the 503B Exclusion: Patient-Safety Groups Endorse, Compounders Push Back
Patient-safety advocates and compounding industry groups stake out opposing positions on the FDA's 503B GLP-1 exclusion. The shape of the June 30 comment-period fight.
FDA Proposes Excluding Semaglutide, Tirzepatide, and Liraglutide From the 503B Bulks List
FDA proposes excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list, citing 'no clinical need.' What it changes, what it doesn't, and what comes next.
FDA to Review Seven Peptides for 503A Compounding List at July PCAC Meeting
FDA's PCAC will evaluate BPC-157, KPV, TB-500, and four more peptides for 503A compounding status July 23–24. What the evidence says and what it means.
FDA Approves Wegovy HD: Higher-Dose Semaglutide Delivers 18.7% Weight Loss in Accelerated Review
FDA approved Wegovy HD (semaglutide 7.2 mg) via accelerated 54-day review. STEP UP trial shows 18.7% weight loss at 72 weeks. Full evidence breakdown.
What the April 22 FDA Category 2 Removal Actually Means (and Doesn’t)
What the April 22 FDA Category 2 Removal Actually Means (and Doesn’t) April 21, 2026 — one day before the […]
The FDA Is Naming Names: Warning Letters Hit Five Research Peptide Vendors
The FDA Is Naming Names: Warning Letters Hit Five Research Peptide Vendors The agency’s crackdown on gray-market peptide suppliers is […]
FDA to Review Seven Peptides for 503A Compounding List at July PCAC Meeting
A landmark 503A peptide review is now officially underway. The FDA announced on April 16, 2026, that its Pharmacy Compounding […]
The FDA Just Scheduled the Most Consequential Peptide Meeting in Years
The FDA peptide reclassification process took its most significant step forward on Tuesday. On Tuesday, the FDA announced it will […]
FDA Approves Foundayo (Orforglipron) — First Oral GLP-1 for Weight Loss With No Food or Water Restrictions
The FDA approved Eli Lilly’s Foundayo (orforglipron) on April 1, 2026, making it the first oral GLP-1 receptor agonist for […]
FDA Approves Icotyde — First Targeted Oral Peptide for Psoriasis
The FDA approved Icotyde (icotrokinra) on March 18, 2026, for moderate-to-severe plaque psoriasis in adults and adolescents aged 12 and […]
FDA Sharpens Enforcement on Compounded GLP-1 Drugs as Shortage Era Ends
The FDA has publicly signaled its intent to take enforcement action against non-approved GLP-1 drugs — a shift that follows the […]