FDA Approves Higher 2 mg Dose of Ozempic for Type 2 Diabetes
The FDA approved a new 2 mg dose of Ozempic (semaglutide) injection, providing an additional option for patients needing more intensive glycemic management.
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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the agency's actual paper trail: approval letters, warning letters, PCAC meeting minutes, 503A bulks list rulings, draft guidance, and Citizen Petitions on substances ranging from semaglutide to BPC-157.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.
Compounded GLP-1 Prescriptions Keep Rising Despite FDA Crackdown
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.
Washington Post Editorial: RFK Jr.'s Peptide Advocacy Is 'Hypocritical Quackery'
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.com Shuts Down After FDA Enforcement Wave
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.