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FDA Panel Backs Wider Access To Six Peptide Therapies, Citing Grey Market Concerns

Zero Rss
1 week 4 days ago
FDA Panel Backs Wider Access To Six Peptide Therapies, Citing Grey Market Concerns

Via American Greatness,

A Food and Drug Administration (FDA) advisory panel has voted to recommend expanding legal access to six popular peptide compounds. Supporters say it could pull patients out of the unregulated grey market that has flourished under years of federal inaction.

The FDA's Pharmacy Compounding Advisory Committee reviewed seven peptides during a two-day hearing in Maryland last week, weighing whether each should be added to the agency's Section 503A Bulks List. Reuters reported the panel voted in favor of moving six forward: BPC-157 for ulcerative colitis, TB-500 and KPV for wound healing, MOTS-c for obesity and osteoporosis, Semax for cerebral ischemia, migraine and trigeminal neuralgia, and Epitalon for insomnia.

Peptides are short chains of amino acids that help regulate metabolism, growth and tissue repair, according to the Cleveland Clinic. Some, including insulin and GLP-1 weight loss drugs, are already FDA approved, while others have remained in regulatory limbo even as demand exploded among patients seeking help with weight loss, muscle building, chronic disease and performance.

If the FDA ultimately adopts the recommendation, licensed compounding pharmacies could prepare the peptides for valid prescriptions, giving patients a legitimate alternative to unregulated online vendors who have filled the gap left by federal delay.

Jim LaValle, a Texas based clinical pharmacist who chairs the International Peptide Society and testified at the hearings, said the vote was not a rubber stamp but a meaningful step toward accountability. "This was not FDA approval, nor was it a blanket endorsement of every peptide, every use or unrestricted access," he told Fox News Digital. "I have said throughout this process that you do not solve a quality problem by forcing the market underground."

LaValle said he was encouraged because the recommendation creates a path away from unverified research use only products and toward oversight by qualified clinicians and licensed pharmacies. He described the right model as access paired with guardrails: trained clinicians, licensed pharmacies, validated quality testing and consistent patient follow up.

"My hope is that the FDA follows the recommendation with a transparent, science-driven process, establishes clear, peptide-specific standards, and follows the guidance for approving a substance that meets the FDA's current regulations," LaValle said, adding that the process should include verifying that both active ingredients and finished products meet quality standards and tracking any side effects.

LaValle cautioned that the committee's vote is only a recommendation, not final FDA approval, and that compounded medications are regulated differently than fully approved drugs. He urged patients to avoid research use only products sold online and to work only with licensed clinicians and pharmacies. "The peptide revolution is here," he said. "However, don't expect miracles. Better choices related to diet, exercise, gut health, sleep, stress and managing metabolic health, guided by regular lab assessments, should be the goal."

The FDA will now weigh the recommendation before issuing a final decision.

Tyler Durden Wed, 07/29/2026 - 12:05
Tyler Durden

NYC teen killed in e-bike crash after ramming into SUV near City Hall

NY Post
1 week 4 days ago
A 17-year-old e-bike rider died when he rammed into a moving SUV near City Hall during Thursday’s morning rush, police said. The teen was pedaling northbound on Centre Street near the busy Chambers Street intersection just before 9 a.m. when he veered out of the bike lane and into the vehicular lane, authorities said. That’s...
Joe Marino, Amanda Woods

NANO Nuclear Expands Air Force Footprint With Second AFWERX Award

Zero Rss
1 week 4 days ago
NANO Nuclear Expands Air Force Footprint With Second AFWERX Award

NANO Nuclear Energy has been selected for a new AFWERX Small Business Innovation Research Phase I award, giving the company another opportunity to advance its KRONOS MMR Energy System with the Department of the Air Force.

The new Phase I award is framed as a broad research and development agreement. NANO said the contract is focused on using KRONOS to “address the most pressing challenges in the DAF [Department of the Air Force].”

The distinction between this award and NANO’s previous Air Force contract is worth noting. 

Last year’s roughly $1.25 million Direct-to-Phase II award was tied to a specific objective: studying the feasibility of deploying a KRONOS MMR at Joint Base Anacostia-Bolling in Washington, DC. That work examines the base’s energy requirements, grid vulnerabilities, siting options, environmental considerations and regulatory pathways.

Rather than evaluating a reactor for one predetermined location, the new engagement could give NANO a wider platform to demonstrate how KRONOS might support energy resilience across additional Air Force installations and potentially other defense applications. It arrives as the military is moving ahead with microreactor projects at several bases, reflecting growing concern over fragile commercial grids and the need for dependable, on-site power.

Of course, an early-stage government award should not be confused with a reactor purchase order. There is still plenty of engineering, licensing and bureaucracy standing between an SBIR contract and an operating nuclear plant.

Still, NANO now has multiple active Air Force engagements instead of a single feasibility study. The earlier Phase II contract gave the company a concrete deployment target, while this broader Phase I award could give it something potentially more valuable over the long run.

Tyler Durden Wed, 07/29/2026 - 11:45
Tyler Durden

Ukraine's FM Claims Attack On Iranian Ship In Caspian Sea Was 'Unintentional'

Zero Rss
1 week 4 days ago
Ukraine's FM Claims Attack On Iranian Ship In Caspian Sea Was 'Unintentional'

The week started with a bizarre incident in the Caspian Sea involving an Iranian commercial vessel and the Iranian military, an episode which threatened to expand the war by merging two conflict theatres.

Iran had accused Ukraine of attacking an Iranian commercial vessel by long-range drone in the Caspian Sea on Saturday, which resulted in an explosion that killed one sailor and injured another.

Soon after, Iran's Ministry of Foreign Affairs summoned Ukraine’s chargé d’affaires in Tehran to severely protest the "hostile and criminal" attack, IRNA reported.

Iran's Foreign Minister Abbas Araghchi has warned that the "blatant UN Charter violation" which was "done at Israel's behest" could serve to "drag Europe into its war." Araghchi also denounced and attacked Zelensky personally, calling him the "freeloader in Kyiv".

But on Tuesday, there was a rapid walk-back and climb-down of sorts regarding the whole murky incident.

Iranian Foreign Minister Abbas Araghchi newly stated that Ukraine's foreign minister assured him that the Ukrainian drone attack on the Iranian commercial vessel was "unintentional".

via Mappr

"Was assured by Ukrainian FM [Andrii Sybiha] that the attack on an Iranian ship was unintentional and Ukraine seeks no escalation," Araghchi wrote on X. "Iran does not seek escalation either, but made clear any attack on our citizens or interests is unacceptable. There must be restitution for losses."

Ukraine's top diplomat Andrii Sybiha‎ in turn didn't exactly deny it was an intentional attack; however, he did acknowledge that a civilian vessel was struck, and not a military one.

"I reiterated that all of Ukraine’s actions are aimed solely at defending our country from Russian aggression and never intended to target civilian vessels or people," Sybiha said after a call with Araghchi.

"This is also true with regard to Iran’s statements about their national who died and a civilian vessel that was targeted in a recent incident. Our goal is to counter Russian aggression, which is the root cause of all incidents, and it is Russia who bears full responsibility for all provocations and casualties," he added.

So it seems the two sides have agreed to downplay the attack incident and just move on. And yet what makes this bizarre and unexpected is that Ukraine seemed to initially be openly boasting of the escalation.

President Zelensky himself announced soon after on X, "We also have very good results from long-range strikes in the waters of the Caspian Sea. In particular, these are vessels that were involved in transporting military cargo from Iran, and a warship."

It is also perplexing how a long-range drone attack on a maritime vessel, presumably hundreds of miles away and which would require very precision targeting, could result in a direct hit and yet be 'unintentional'.

Anonymous (not verified) Wed, 07/29/2026 - 11:25
Anonymous

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