A U.S. Food and Drug Administration advisory panel recently considered whether compounding pharmacies should be permitted to manufacture multiple peptides. According to the source, the panel recommended that pharmacies be allowed to manufacture epitalon and semax, while it voted narrowly against permitting manufacture of emideltide. These votes came after an earlier panel decision, described in the source as occurring on Thursday, that recommended allowing pharmacies to make four other peptides.
The article does not report specific vote tallies, the names of the four peptides recommended on the prior day, or other procedural details about the panel deliberations. Those details were not provided in the source material.
The source notes that peptides have grown in popularity in the United States, in part driven by endorsements from social media influencers. The panel’s recommendations are presented as advancing an objective of U.S. Health and Human Services secretary Robert F. Kennedy Jr. to make certain unapproved compounds more available to Americans. The article frames the panel votes as steps toward that policy goal but does not provide further commentary from HHS or the panel members in the published piece.
This story appears as part of a Pharmalittle column and is behind the STAT+ subscriber paywall for full coverage. The publicly available portions summarize the panel outcomes and context but omit several specifics. The source does not report exact vote counts, the full list of peptides under consideration, the panel’s balancing of safety and efficacy data for each peptide, or any planned regulatory steps following the recommendations. Where the source is silent, no additional facts are reported here.
Separately, the source reports that Amgen has submitted new evidence to the FDA and is seeking a hearing to challenge a proposed agency action to withdraw the drug Tavneos from the U.S. market. According to the article, the FDA proposed withdrawing Tavneos in April, citing a lack of proven effectiveness and alleging false statements in the original marketing application. The source characterizes Tavneos as a treatment for a rare autoimmune disease that damages blood vessels; no additional clinical details or specific disease name were included in the published excerpt.
Amgen, as described in the source, strongly disagrees with the FDA’s proposed withdrawal. The company states that its submission to the agency includes more than 70 real-world studies involving over 2,200 patients, which Amgen says support Tavneos’s effectiveness and safety. The source does not provide details on the designs, endpoints, outcomes, or peer-reviewed status of those studies, nor does it report any FDA response to the newly submitted material beyond the fact that Amgen is seeking a hearing.
This item is presented in STAT’s Pharmalittle column. Portions of the coverage are available only to STAT+ subscribers. The public excerpt includes the key points summarized above but omits some procedural and evidentiary specifics that were not reported in the accessible source material.
Summary
An FDA advisory panel recommended permitting compounding pharmacies to make epitalon and semax, and narrowly recommended against emideltide, continuing a trend of recent panel actions to allow certain peptides. The panel decisions align with federal leadership interest in broader access to unapproved peptide compounds. Separately, Amgen is contesting the FDA’s proposed withdrawal of Tavneos, submitting a dossier of real-world studies and seeking a hearing. The source provides no vote counts, detailed data on the peptides or the Tavneos evidence, or the FDA’s immediate responses beyond the proposed withdrawal action.