News & Pipeline

Verified May 8, 2026: On April 30, FDA proposed permanently removing semaglutide, tirzepatide, and liraglutide from the 503B outsourcing bulk list — forever, not just during shortage enforcement. Public comment closes June 29, 2026. If finalized, no 503B pharmacy could bulk-compound these GLP-1 drugs in the future, even if a new shortage is declared. 503A patient-specific compounding under medical-necessity remains unaffected.

Updated May 2026: 5 next-gen obesity drugs in Phase 3. Retatrutide (Lilly) 28.7% weight loss. CagriSema (Novo): REDEFINE-1 22.7% (obesity), REDEFINE-2 15.7% (T2D), PDUFA expected October 2026. MariTide (Amgen, monthly), survodutide, Foundayo approved April 2026. FDA approvals 2026-2028.

HHS Secretary Robert F. Kennedy Jr. is considering a regulatory framework for Medicare and Medicaid GLP-1 coverage, but only for patients who have 'exhausted other options' — specifically glucose monitors (~$80/month), diet changes, and exercise. Verified April 2026: what Kennedy said on CBS News April 15 and at the House Ways and Means hearing April 16, how the gate would work, and how it stacks with the already-announced Medicare GLP-1 Bridge launching July 2026.

Medicare will begin covering GLP-1 weight loss medications at $50/month starting July 2026. Here's who qualifies, how it works, and what comes next.

Verified April 2026: Retatrutide (Eli Lilly, LY-3437943) achieved 28.7% body weight loss in Phase 3 TRIUMPH trials — nearly double semaglutide (14.9%) and 37% higher than tirzepatide (20.9%). First triple-agonist (GLP-1 + GIP + glucagon). FDA approval expected late 2027 to early 2028.

Verified April 11, 2026: Foundayo (orforglipron) shipped to LillyDirect patients starting April 6. First-week fill rate hit 94% within 48 hours of order. Pricing confirmed: $649/mo self-pay, $25/mo with commercial insurance + Lilly savings card. Here's exactly how to order today.

Verified April 11, 2026: The FDA issued 14 new warning letters to GLP-1 compounders between March 12 and April 8, 2026 — the largest enforcement wave since the semaglutide compounding ban. Full list of affected pharmacies, what they violated, and what to do if you were a patient.

The FDA just approved Eli Lilly's Foundayo (orforglipron) — the only GLP-1 weight loss pill with no food, water, or timing restrictions. Here's what it costs, how it works, and how it compares to Wegovy and Zepbound.