272 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.
The FDA published warning letters targeting companies marketing GLP-1 receptor agonists without regulatory approval, addressing CGMP violations and clinical trial protocol failures.
Labs report about a third of peptide products fail basic quality checks as the underground market explodes. Texas-based Finnrick processes ~60,000 samples per year, up from a handful per month.
MEDVi, a $1.8B AI-powered telehealth company with just two full-time employees, received an FDA warning letter in February 2026 for misbranding compounded semaglutide and tirzepatide.
The UK's medicines regulator is investigating whether clinics are breaking the law by making unsubstantiated medicinal claims for unregulated peptide therapies.
Three former officials maintain the 2023 decision to deem 19 peptides unsafe for compounding was grounded in documented safety concerns, countering Kennedy's claims on Joe Rogan.
The MHRA is investigating whether UK peptide clinics are breaking the law by making medicinal claims for unregulated peptides like BPC-157 and Thymosin Alpha. Clinics were found charging £350–£450/month per peptide despite labeling them "research only."
The FDA announced steps to restrict compounded GLP-1 products, specifically naming Hims & Hers. Novo Nordisk has also sued Hims & Hers over compounded semaglutide.
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.
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.
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.
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.
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 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.
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'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.
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.
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.
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.