News & articles
FDA Approves MIMRYLO (Rusfertide), a Hepcidin-Mimetic Peptide for Polycythemia VeraThe FDA approved rusfertide (MIMRYLO) on August 28, 2026 for polycythemia vera patients needing frequent phlebotomy—marking the first hepcidin-mimetic peptide therapy in the United States.
- FDA Grants Fast Track to PVX108 Peanut Peptide Immunotherapy
PVX108 received FDA Fast Track designation in August 2026 as a synthetic T-cell epitope peptide therapy for peanut allergy—one of the first allergen immunotherapy programs built entirely on short peptides rather than whole extracts.
- GLP-1 Bulk-Drug Comment Period Closes; Thousands of Filings on 503B Peptide Access
FDA logged roughly 3,900 public comments by the July 30, 2026 deadline on whether GLP-1 bulk substances belong on the 503B bulks list—one of the agency's busiest compounding dockets ever.
- Lilly Reports Phase 3 TRIUMPH Data for Retatrutide, a GLP-1/GIP/Glucagon Triple Agonist
Eli Lilly's July 2026 TRIUMPH Phase 3 topline showed retatrutide produced up to 28.7% mean weight loss at 68 weeks in obesity patients without diabetes, sending ripples through the peptide supply chain.
- FDA Advisory Panel Backs Six Peptides for 503A Bulks-List Consideration
The FDA Pharmacy Compounding Advisory Committee recommended six peptide bulk substances for 503A list consideration after two days of safety, sourcing, and dosing testimony in July 2026.