FDA Panel Ends Peptide Review Backing Six of Seven, with Emideltide Rejected in a 6 to 7 Vote

FDA's Pharmacy Compounding Advisory Committee voted to add six of seven peptides to the 503A Bulks List, allowing compounded pharmacy preparation; emideltide (delta sleep-inducing peptide) was rejected 6-7, the only substance the panel denied despite overriding FDA staff recommendations on all others. The votes are advisory only and do not change patient access or insurance coverage until formal FDA rulemaking concludes.

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