FDA finds no suicide risk with GLP-1s, oral Wegovy draws explosive demand, Lilly's Foundayo launches at $25/month, and a Utah physician is indicted for importing peptides.
10 stories · Covering regulatory, industry, clinical-trials, research
Today's peptide news cycle is dominated by a major FDA safety finding, the explosive launch of oral GLP-1 pills, and a continuing media blitz questioning the safety of unregulated peptide therapies. The FDA concluded that GLP-1 medications carry no increased suicide risk, requesting removal of warning labels — a significant win for the drug class. Meanwhile, Novo Nordisk's oral Wegovy pill is drawing a wave of new patients three months into its launch, and Eli Lilly's Foundayo (orforglipron) hit the market at $25/month for insured patients. On the enforcement front, a Utah physician was indicted for importing misbranded peptides from China, and 5,000 units were seized at the border.
Based on analysis of 107,910 patients, the FDA concluded there is no increased suicide risk associated with GLP-1 medications and has requested removal of related warning labels.
Three months into its launch, oral Wegovy has driven explosive prescription demand, largely attracting new patients who avoided injections. Early data suggest the pill is expanding the obesity market rather than cannibalizing injectable users.
Eli Lilly launched Foundayo on April 1 at $25/month for insured patients and $149 self-pay. The ATTAIN-1 trial showed 12.4% average body weight loss on the highest dose.
Noom acquired Tailor Made Compounding, a licensed 503A pharmacy in 46 states serving 400+ clinics, offering compounded peptides including sermorelin, GHK-Cu, and oxytocin.
A Utah physician was indicted for importing and selling misbranded drugs from China to over 200 patients. Customs separately seized 5,000 unapproved peptide units at the border.
The FLOW trial showed semaglutide reduced major kidney events by 24%, and retatrutide demonstrated up to 28.7% weight loss in TRIUMPH-4. The full pipeline including CagriSema, MariTide, and survodutide was presented.
Comprehensive review examining GLP-1 receptor agonists for neurological conditions. A recent NEJM trial showed GLP-1 treatment resulted in less motor disability progression at 12 months.
Amazon Pharmacy expanded access to the new oral Wegovy pill with both insurance and cash-pay options, signaling a broader retail push to capitalize on surging oral GLP-1 demand.
The UK's MHRA is investigating peptide clinics promoting BPC-157, MOTS-C, and Cortexin with unproven claims. Making medicinal claims classifies these products as medicines under UK law.
The FDA published warning letters targeting companies marketing GLP-1 receptor agonists without regulatory approval, addressing CGMP violations and clinical trial protocol failures.