119 stories
FDA coverage on Peptide News Digest follows the agency's actual paper trail: approval letters, warning letters, PCAC meeting minutes, 503A bulks list rulings, draft guidance, and Citizen Petitions on substances ranging from semaglutide to BPC-157.
The center of gravity in 2025 and 2026 has been compounding. Once GLP-1 shortages resolved, the agency turned to enforcement — 503A patient-specific compounding versus 503B outsourcing, which APIs sit on which list, what counts as a 'clinical need,' and whether additive formulations count as new drugs. The April 30, 2026 proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list is the most consequential single move so far.
Outside GLP-1, the FDA has been active on peptide-vendor warning letters, advisory committee votes (PCAC, Endocrinologic and Metabolic Drugs), and the long grind of Section 503A's bulks list. Browse the latest below.
The FDA published warning letters targeting companies marketing GLP-1 receptor agonists without regulatory approval, addressing CGMP violations and clinical trial protocol failures.
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 FDA announced steps to restrict compounded GLP-1 products, specifically naming Hims & Hers. Novo Nordisk has also sued Hims & Hers over compounded semaglutide.
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.
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.
Hims & Hers stock briefly rallied on reports the FDA may ease peptide restrictions, but gains reversed. The company had proactively acquired a peptide production facility in California in 2025.
Digital health companies are betting on peptides as the next big wellness category. They're banking on HHS Secretary RFK Jr. getting the FDA to lift restrictions on certain peptides.
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.
Hims & Hers Health stock rose on reports the FDA is preparing to allow compounding pharmacies to produce previously banned injectable peptides, potentially expanding the telehealth company's operations.
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.
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.
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.
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.
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.
Analyzes the announcement that ~14 of 19 peptides on FDA's Category 2 list will move back to Category 1, restoring access through licensed compounding pharmacies with a prescription.