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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the agency's actual paper trail: approval letters, warning letters, PCAC meeting minutes, 503A bulks list rulings, draft guidance, and Citizen Petitions on substances ranging from semaglutide to BPC-157.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 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.
APC CEO Scott Brunner discusses the regulatory landscape for compounded GLP-1 receptor agonists amid increasing scrutiny and legal battles over compounded peptide drugs.
The FDA approved a new formulation of tesamorelin, the only approved treatment for HIV-associated excess abdominal fat, representing continued investment in peptide therapeutics for rare conditions.
Updated explainer clarifying BPC-157 is not outright banned but in Category 2 requiring further investigation. Discusses potential shifts after public statements about moving peptides back to Category 1.
The FDA held a public meeting to discuss broadening supplement ingredient criteria to include peptides, probiotics, and other substances. This is the first such meeting since RFK Jr. became HHS Secretary.
Health Secretary Kennedy announced on Joe Rogan's podcast that the FDA will soon reclassify about 14 peptides currently restricted from compounding pharmacies, aiming to curb gray-market sourcing.
The FDA granted breakthrough therapy designation to survodutide, a dual glucagon/GLP-1 receptor agonist by Boehringer Ingelheim, for treating adults with MASH.
FDA approved setmelanotide (IMCIVREE), an MC4R agonist peptide, for reducing body weight in adults and children aged 4+. Phase 3 TRANSCEND trial showed 18.4% placebo-adjusted BMI reduction at 52 weeks.
The FDA approved a new 2 mg dose of Ozempic (semaglutide) injection, providing an additional option for patients needing more intensive glycemic management.
Healthcare Brew reports that despite the FDA sending thousands of warning letters since September 2025, compounded semaglutide and tirzepatide prescriptions have increased since the semaglutide shortage ended in February 2025. About 80% of compounded GLP-1 prescriptions now include supplemental ingredients like B vitamins to avoid being classified as exact copies of FDA-approved drugs.
The Washington Post editorial board published a sharp critique of Health Secretary Kennedy, arguing that his insistence on rigorous evidence for vaccines while simultaneously pushing the FDA to deregulate peptides with minimal human safety data represents a dangerous double standard in public health policy.
PeptideSciences, one of the largest grey-market research peptide vendors in the US reportedly generating over $7 million per month, voluntarily ceased all operations on March 6. The shutdown followed coordinated enforcement from the FDA, DOJ, and FBI targeting companies selling compounds like semaglutide and tirzepatide without pharmaceutical licensing.