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FDA Advisory Panel Recommends Expanded Compounding Access for Six Peptides
An FDA advisory panel has voiced support for allowing continued compounding access to six peptide compounds, a step that could preserve patient and practitioner access while formal approval decisions proceed.
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FDA Advisory Panel Backs Easing Restrictions on Six Peptides
An FDA advisory panel has voted in favor of loosening restrictions on six peptide compounds, a step that could expand access for researchers and compounding use. The panel’s discussion also touched on continued monitoring to ensure safety as access broadens.
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Phase II Trial Begins Dosing Patients with LSALT Peptide, a Potential Organ-Protection Therapy
A Phase II clinical trial evaluating LSALT peptide has begun dosing patients, marking a key step forward for a therapy being studied to help protect organ function during high-risk medical procedures.
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FDA Advisory Panel Votes to Ease Restrictions on Six Peptides
An FDA advisory panel has voted in favor of easing restrictions on six peptides, a step that could expand access for research and compounding use. The decision reflects growing regulatory recognition of peptides’ therapeutic potential.
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FDA Approves MIMRYLO (Rusfertide), a Novel Hepcidin Mimetic Peptide, for Polycythemia Vera
The U.S. FDA has approved Protagonist Therapeutics’ rusfertide, marketed as MIMRYLO, a first-in-class hepcidin mimetic peptide for treating polycythemia vera. The approval marks a significant milestone in peptide-based therapies for blood disorders.
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FDA Advisory Panel Endorses Expanded Access for First Four Peptides Under Review
An FDA advisory committee has voted in favor of easing restrictions on four previously unapproved peptides, marking a significant step toward broader access for patients and practitioners.
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FDA Advisory Panel Backs Continued Compounding Access for Six Peptides
An FDA advisory committee has recommended that six out of seven reviewed peptides remain eligible for pharmacy compounding, preserving patient access to these therapies. The decision reflects a favorable risk-benefit assessment for the majority of substances under review.
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Lilly’s Retatrutide Hits Key Goals in First Phase 3 Trial for Type 2 Diabetes
Eli Lilly’s triple agonist retatrutide showed significant reductions in both A1C and body weight in its first Phase 3 trial, marking an encouraging step forward for type 2 diabetes treatment.
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Gan & Lee Advances Oral Amylin Peptide ASC36 Into Phase 1 Trial for Obesity
Gan & Lee Pharmaceuticals has initiated a U.S. Phase 1 trial for ASC36, an oral amylin peptide designed to offer a differentiated approach to obesity treatment. The trial marks an early but promising step toward expanding oral options in the metabolic disease space.
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TwoStep Therapeutics Secures $62.5 Million and FDA Clearance to Advance Novel Peptide-Drug Conjugate
TwoStep Therapeutics has closed an oversubscribed $62.5 million Series A financing round and received FDA clearance to begin clinical trials of its first-in-class peptide-drug conjugate, marking a major step forward for the emerging therapeutic platform.