FDA decision calendar

Editorial projection for retatrutide, Eli Lilly's triple agonist (GLP-1/GIP/glucagon). No NDA filing or PDUFA date has been published; Phase 3 TRIUMPH trials are ongoing and the mid-2027 placement is our estimate, not an FDA-published date.

Novo Nordisk's semaglutide + cagrilintide combination (CagriSema) is expected to file with FDA in the 2026-2027 timeframe based on the phase 3 REDEFINE program. No filing or action date has been published; the placement is our editorial estimate.

Boehringer Ingelheim survodutide (dual GLP-1/glucagon agonist) Phase 3 SYNCHRONIZE-1 trial readout expected Q2 2027. Will inform FDA filing timeline.

Novo Nordisk's amycretin, a single-molecule GLP-1/amylin receptor co-agonist, progressing through clinical development. Phase 3 program initiation expected 2027-2028 (editorial projection — no published date).

FDA approved Foundayo (orforglipron), Eli Lilly's once-daily oral GLP-1 receptor agonist, for chronic weight management. It is not approved for type 2 diabetes.

Outcome: Approved April 1, 2026 for chronic weight management only. Taken with or without food. LillyDirect self-pay: $149/month (0.8 mg and 2.5 mg), $199 (5.5 mg), $299 (9 mg, 14.5 mg, 17.2 mg).

Hims & Hers exited compounded semaglutide prescribing on March 9, 2026 under a settlement of Novo Nordisk's February 2026 lawsuit, after briefly launching a compounded oral semaglutide product.

Outcome: Hims transitioned existing subscribers to brand-name Wegovy via insurance OR direct-pay channels. Compounded semaglutide largely unavailable from major telehealth platforms after this milestone.

Eli Lilly updated Zepbound prescribing information to formalize alopecia as a reported adverse event (mirroring Wegovy label) and to add explicit 2-month pre-pregnancy washout recommendation.

Outcome: Label updated. Alopecia officially listed; pre-pregnancy 2-month washout aligned with Wegovy guidance.

Novo Nordisk launched NovoCare Pharmacy in March 2025, selling brand-name Wegovy directly to cash-paying patients and creating direct competition for compounding pharmacies.

Outcome: Direct-pay live from March 2025, no insurance required, bypassing prior authorization. Current price (September 2026): $349/month for Wegovy pens, $199/month for the first two fills of 0.25 mg and 0.5 mg for new patients through December 31, 2026.

FDA officially declared the semaglutide (Wegovy/Ozempic) shortage resolved, ending the 503A compounding-pharmacy carve-out that allowed compounded semaglutide during the shortage.

Outcome: Shortage status removed. Compounded semaglutide production wound down with 60-day grace period. Telehealth platforms relying on compounded sources discontinued the offering or transitioned to brand-name supply.

FDA approved Zepbound (tirzepatide) for the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity, based on SURMOUNT-OSA trials. First and only prescription medication approved for OSA.

Outcome: Approved. Opens a separate insurance pathway for patients with documented OSA — often simpler PA than weight-loss indication alone.

FDA reaffirmed the tirzepatide (Zepbound/Mounjaro) shortage as resolved in December 2024 (after first removing it in October 2024, then re-evaluating amid litigation), ending the compounding carve-out for compounded tirzepatide.

Outcome: Shortage status removed. Compounded tirzepatide production wound down. Brand-name Zepbound supply now adequate at most retail and specialty pharmacies.

Eli Lilly launched LillyDirect Self-Pay in August 2024, selling brand-name Zepbound vials directly to cash-pay patients at prices below the pen list price.

Outcome: Vial self-pay live from August 2024 (drawn into a syringe rather than a pen), no insurance required. Current prices (September 2026): $299 (2.5 mg), $399 (5 mg), $449 (7.5-15 mg) when refilled within 45 days.

FDA expanded Wegovy approval to include reducing the risk of major cardiovascular events (MACE) in adults with established cardiovascular disease and BMI ≥27. Based on SELECT trial showing 20% MACE reduction.

Outcome: Approved. Patients with established CVD now have a separate authorization pathway — does NOT require 6-month lifestyle attempt OR step therapy that obesity indication typically demands.

FDA approved Wegovy for chronic weight management in adolescents aged 12 and older with obesity (BMI at or above 95th percentile for age and sex). First weight-loss GLP-1 approved for pediatric use.

Outcome: Approved. Same dose ladder as adults (0.25 → 2.4 mg weekly). Now covered for adolescent populations under most commercial plans with prior authorization.