Name: Foundayo phase 3 CV safety analysis clears, Q4 launch planned
Start: 2026-05-14

Every FDA action that materially affects the GLP-1 telehealth landscape, from Byetta in 2005 to Foundayo in 2026. Each entry carries Event schema so Google rich results and AI search engines can extract the chronology.

2005-04-29

FDA approves Byetta (exenatide)

First GLP-1 receptor agonist approved in the United States. For type 2 diabetes. Twice-daily injection.

2010-01-25

FDA approves Victoza (liraglutide) for T2D

Daily injection. Manufacturer: Novo Nordisk.

2014-09-23

FDA approves Saxenda (liraglutide 3.0 mg)

First GLP-1 receptor agonist approved for chronic weight management.

2014-09-18

FDA approves Trulicity (dulaglutide)

Weekly GLP-1 receptor agonist for T2D.

2017-12-05

FDA approves Ozempic (semaglutide) for T2D

Weekly injection. First weekly semaglutide product.

2019-09-20

FDA approves Rybelsus (oral semaglutide)

First oral GLP-1 receptor agonist for T2D. Uses SNAC absorption enhancer.

2020-01-16

FDA expands Ozempic to reduce CV risk in T2D + CV disease

Based on SUSTAIN-6 outcomes.

2021-06-04

FDA approves Wegovy (semaglutide 2.4 mg)

Chronic weight management indication for adults with obesity. Basis: STEP-1 trial.

2022-05-13

FDA approves Mounjaro (tirzepatide) for T2D

First dual GIP/GLP-1 agonist.

2023-11-08

FDA approves Zepbound (tirzepatide)

Chronic weight management indication. Basis: SURMOUNT-1 trial.

2023-12-22

FDA places semaglutide injection back on shortage list (resolved)

Tracks supply during peak Wegovy demand.

2024-03-08

FDA approves cardiovascular indication for Wegovy

First weight-management drug ever approved for a cardiovascular outcome (MACE reduction). Basis: SELECT trial.

2024-08-02

FDA resolves tirzepatide shortage

Begins enforcement transition for mass-market 503B compounded tirzepatide.

2024-12-20

FDA approves Zepbound for OSA in adults with obesity

First drug ever FDA-approved for obstructive sleep apnea. Basis: SURMOUNT-OSA trial.

2025-02-21

FDA resolves semaglutide shortage

Begins enforcement transition for mass-market 503B compounded semaglutide.

2025-05-22

FDA outlines plan to restrict ingredients in mass-marketed compounded GLP-1s

Agency framework targets unapproved formulations and misleading ads on direct-to-consumer telehealth platforms.

2025-08-15

Multiple state pharmacy boards open investigations into mass-market GLP-1 compounding

Florida, Texas, California pharmacy boards review high-volume 503A operations following adverse-event clusters.

2026-03-12

FDA approves Foundayo (orforglipron) for chronic weight management

First oral, small-molecule (non-peptide) GLP-1 receptor agonist. Manufacturer: Eli Lilly. Basis: ATTAIN-1 trial.

2026-04-28

CMS expands Part D coverage of semaglutide 2.4 mg under SELECT-aligned pathway

Medicare beneficiaries with BMI ≥27 and established CVD become eligible for Wegovy coverage.

2026-05-03

FDA 503B enforcement period for compounded sema/tirz fully concludes

503A patient-specific compounding continues; 503B bulk production ends for these molecules.

2026-05-14

Foundayo phase 3 CV safety analysis clears, Q4 launch planned

Eli Lilly confirms commercial supply for obesity indication in Q4 2026.

Why this timeline matters

Compounded GLP-1 regulation, brand-name drug approvals, and shortage-list status are tightly linked. A telehealth program can legally produce compounded semaglutide under broader 503B rules when the FDA-approved product is on shortage; once the shortage resolves, 503B bulk production must stop, but 503A patient-specific compounding may continue. The dates above mark every regulatory turn in this story.

Sources

All entries are sourced to FDA press announcements, Federal Register notices, FDA labels, or directly verified manufacturer announcements. See our research bibliography for the primary trial references that underpin many of these approvals.