FDA and Novo Nordisk Warn of GLP-1 Telehealth Compounding Takedown
The FDA announced steps to restrict compounded GLP-1 products, specifically naming Hims & Hers. Novo Nordisk has also sued Hims & Hers over compounded semaglutide.
Regulatory News
104 stories across all digests
Regulatory coverage on Peptide News Digest tracks how the FDA, MHRA, EMA, and state agencies handle peptides — what they let through, what they pull, what they redefine.
The compounding fight has dominated 2025 and 2026. GLP-1s came off the FDA shortage list in early 2025; the agency moved compounded semaglutide and tirzepatide toward Category 2 on the 503A bulks list; and a wave of state legislation tried to either preserve or shut off telehealth access. The PCAC has spent meetings on BPC-157, GHK-Cu, and other research peptides that have built consumer demand without clinical infrastructure behind them.
Stories here name the agency, the substance, and the action. Browse the latest below, or jump to specific tags like #fda, #compounding, #peptide-policy, or #503a.
India Tightens Watch on GLP-1 Drugs Amid Safety and Misuse Concerns
India's drug regulators are intensifying GLP-1 oversight ahead of semaglutide's patent expiry. The Drug Controller General audited 49 entities and issued notices to violators.
RFK Jr. May Reverse FDA Peptide Ban — Former Officials Push Back
ProPublica reveals the potential reversal of the FDA's 2023 ban on 19 compounded peptides. Three former FDA officials, including former acting commissioner Janet Woodcock, say RFK Jr. mischaracterized their work and that documented safety concerns supported the ban.
Rusfertide Receives FDA Priority Review for Polycythemia Vera
Takeda/Protagonist Therapeutics' rusfertide, a first-in-class hepcidin mimetic peptide, received NDA acceptance and priority review. The Phase 3 VERIFY study showed it more than doubled clinical response rates.
FDA Approves Foundayo Under National Priority Voucher Program in Record 50 Days
Foundayo became the first new molecular entity cleared under the Commissioner's National Priority Voucher Program, with review completed 294 days before the PDUFA date. Commercial pricing set at $25/month insured and $149/month self-pay at the lowest dose.
FDA Approves Eli Lilly's Foundayo (Orforglipron) as First Small-Molecule GLP-1 Pill for Obesity
The FDA approved Foundayo, a once-daily oral GLP-1 pill that can be taken any time without food or water restrictions. In trials, patients lost an average of 11% body weight over one year. It was approved under the FDA's National Priority Voucher program.
India's CDSCO Tightens Oversight on GLP-1 Drugs, Warns Against Weight Loss Misuse
India's Central Drugs Standard Control Organization issued advisories against unsupervised use of semaglutide and tirzepatide for weight loss, cracking down on misleading social media promotions and unapproved compounded versions.
FDA Poised to Reverse 2023 Peptide Ban Following RFK Jr. Advocacy
Federal regulators are moving toward restoring legal access to injectable peptides barred from pharmacy compounding in 2023, which could redirect patients from unregulated online sellers to regulated pharmacy channels.
STAT News: FDA Peptide Compounding Shift and Iran Conflict Impact on Clinical Trials
STAT's pharmaceutical roundup covers the FDA's expected move to allow compounding of previously banned peptides and the impact of the Iran conflict on global clinical trial recruitment.
FDA Expected to Lift Peptide Compounding Ban at RFK Jr.'s Urging
The FDA is moving to allow compounding pharmacies to produce 14+ injectable peptides banned in 2023. Health Secretary RFK Jr. publicly backed the reversal, while top FDA leaders reportedly have reservations about politically-driven decisions.
FDA Warns 30 Telehealth Companies Over Compounded GLP-1 Marketing
The FDA issued warning letters to 30 telehealth firms for false or misleading claims about compounded GLP-1 weight-loss products, signaling a major crackdown on illegal online marketing.
UK Expands Wegovy Prescribing for Cardiovascular Prevention
Under new UK guidance, GPs can prescribe semaglutide (Wegovy) to overweight patients who have had heart attacks, strokes, or serious circulation problems, expanding its use beyond weight management.
Wellness World Eagerly Awaits FDA Peptide Reclassification
Longevity enthusiasts anticipate FDA loosening restrictions on BPC-157, ipamorelin, and MOTs-C. Industry notes it may take months for compounding pharmacies to ramp up supply after reclassification.
FDA Approves Oral Semaglutide as First GLP-1 Pill for Weight Loss
The FDA approved once-daily oral semaglutide (Wegovy) 25 mg as the first GLP-1 pill for weight loss, offering a convenient alternative to injections with comparable weight loss to the original injection.
FDA May Relax Dietary Supplement Warning Label Rules
The FDA is evaluating potential changes to dietary supplement warning label requirements, with pharmacists urged to remain vigilant as regulations may loosen under the current administration.
PBS NewsHour: Dietary Supplement Makers Push FDA to Allow Peptides as New Ingredients
The FDA held a public meeting at the Natural Products Association's request to discuss broadening supplement criteria to include peptides. FDA official Kyle Diamantas emphasized 'cutting red tape' under the Kennedy-era HHS stance.
The Guardian Editorial: RFK Jr. Would Leave Public Health to the Hucksters
The Guardian editorial board criticizes RFK Jr.'s plan to open up ~14 injectable peptides, arguing the MAHA agenda replaces the precautionary principle with 'do your own research' rhetoric benefiting wellness profiteers.
FDA Approves Oral Wegovy Following Positive OASIS 4 Trial Results
FDA approved oral Wegovy (semaglutide) based on OASIS 4 trial showing significant improvements in glycemic control and cardiovascular risk factors. Novo Nordisk plans full US launch from North Carolina manufacturing.