The Department of Health and Human Services (HHS) will let pharmacies produce and sell treatments involving six peptides that aren't specifically approved by the Food and Drug Administration (FDA). The move is meant to provide a "controlled alternative" to buying peptides from possibly sketchy foreign pharmacies, HHS said.

Under the new HHS policy, the agency will not "take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product" using one of six named "peptide bulk drug substance[s]."

This is a major win for peptide proponents, compounding pharmacies, and health freedom—and hints that HHS Secretary Robert F. Kennedy Jr. may be feeling frustration with the slow pace of things at the FDA.

The six peptides in question—BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500—were the subject of a summer meeting of the FDA's Pharmacy Compounding Advisory Committee (PCAC).

Up for debate was whether these six "bulk drug substances" and another, Emideltide, should be put on the FDA's Section 503A Bulks List. That list governs which substances licensed physicians and specialty pharmacies can compound into drug products without them being a component of an already FDA-approved drug or having "an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph."

In July, the panel voted to put six of the seven peptide-related substances under consideration (all except Emideltide) on the bulks list. But the panel's vote is not binding.

It's ultimately up to FDA authorities to decide whether they accept the advisory committee's recommendations. So far, no decision has been released.

But yesterday, HHS unveiled an "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances." And it effectively puts the committee's recommendations into practice by proxy.

Kennedy can't ensure FDA approval, of course. But he can—and will—stop HHS from taking action against physicians or pharmacies that compound and distribute these substances under his prescribed rules.

In an explainer about the new policy, HHS notes that "compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed." Nonetheless, "compounded drugs can serve an important medical need for certain patients" and "there is significant interest in the use of these peptides in compounding," it says.

Opponents of allowing more peptide-based treatments to be compounded by licensed U.S. pharmacies often focus on the fact that these products don't have FDA approval and may not have the extensive experimental backing required of FDA-approved treatments.

But people are already taking BPC-157, MOTS-c, and other peptides anyway, buying them from companies selling them under "for research use only" labels or obtaining them from foreign distributors. Peptides can even be found on discount everything-marketplaces like the China-based AliExpress.

Allowing licensed physicians and pharmacies in the U.S. to compound these substances without fear of being punished gives people access to safer options than they might otherwise have.

Pharmacies compounding peptide-based products under the rules set forth by federal law still have to be licensed in the states where they operate and follow certain rules, including a requirement that active ingredients used for compounding must be "accompanied by valid certificates of analysis" and "be compounded based on the receipt of a valid patient-specific prescription." Per the new HHS policy, they must also follow several other rules regarding the packaging and labeling of these peptides.

"The Secretary of HHS has determined that this limited enforcement-discretion policy will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients," notes the HHS explainer. "By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy provides patients with a more controlled alternative."

It's an astoundingly reality-based policy for government health officials, who often act as if matters like this come down to a binary between perfect health and safety on one hand and certain danger on the other.

Rather than relegating peptides to gray or black markets until they (may be) pronounced all clear by the FDA, RFK Jr.'s HHS has chosen to balance safety with "patient choice and freedom," as the HHS states.

The post RFK Jr. Institutes Backdoor Approval of 6 Peptides appeared first on Reason Magazine.

The European Union is attempting to establish itself as a developer of advanced artificial intelligence rather than primarily a regulator and consumer of technology produced elsewhere. An Italian-led consortium developing a large open-source AI model across all 24 official EU languages will provide an important test of whether Europe’s supercomputing infrastructure can support globally competitive systems.

Europe’s efforts to establish greater control over artificial intelligence technology are entering a new phase as the EUROPA consortium, led by Italian company Domyn, advances plans to develop one of the continent’s largest open-source AI models.

The initiative, supported by the European Commission and European high-performance computing infrastructure, aims to create an advanced artificial intelligence system capable of competing with models developed by leading American and Chinese companies.

Domyn chief executive Uljan Sharka told the Financial Times on 29 October that Europe possesses the technological resources and industrial expertise required to compete in advanced AI development.

However, he also identified two obstacles: the need for greater investment and the difficulty of persuading European businesses to adopt domestically developed systems.

These challenges extend beyond the development of a single language model.

They concern whether Europe can establish a commercially sustainable AI industry while reducing dependence on technology providers headquartered outside the EU.

EUROPA and the Frontier AI Grand Challenge

The European Commission selected EUROPA in June 2026 as the winner of its Frontier AI Grand Challenge.

The competition, launched in February, was designed to support the development of a European general-purpose AI model with more than 400 billion parameters.

EUROPA’s planned model is expected to contain approximately 500 billion parameters and support all 24 official EU languages.

The consortium brings together Domyn and Germany’s Fraunhofer research organisation, including the Fraunhofer IAIS and IIS institutes.

Its work will rely on the EuroHPC network of European supercomputers.

Under the competition arrangements, the winning consortium can obtain access to as much as 2.5 per cent of EuroHPC’s total computing capacity for one year.

This allocation is intended to address one of the largest barriers to advanced AI development: the enormous computing resources required to train models at this scale.

The final system is intended to be released under an open-source licence, allowing organisations to inspect, adapt and deploy the technology.

Nevertheless, parameter count alone does not demonstrate that a model is competitive.

Its actual performance will depend on training data, architecture, computational efficiency, evaluation results and the ability to perform reliably across different tasks.

A European Model for European Languages

One of EUROPA’s distinguishing objectives is its coverage of all official EU languages.

The commercial AI market has historically been dominated by models developed primarily for English-language applications, although leading international systems increasingly support multiple languages.

For Europe, linguistic capability has particular relevance to public administration, legal services, education and cross-border business.

A model designed specifically for the European market could potentially support specialised applications involving national legislation, administrative procedures and technical terminology.

However, multilingual availability will need to be assessed against measurable performance standards.

A system capable of producing fluent responses in a particular language is not necessarily equally reliable when interpreting specialised legal or scientific information.

The consortium will therefore need to demonstrate that linguistic coverage translates into practical capabilities rather than remaining principally a technical specification.

Europe’s Supercomputers Become Strategic Assets

The EUROPA project forms part of a wider effort to use European publicly supported computing infrastructure for commercial and scientific AI development.

The EuroHPC Joint Undertaking has invested in systems intended to provide advanced computing resources to researchers, businesses and public institutions.

Additional AI-focused infrastructure is being developed through the EU’s network of AI factories.

These facilities are intended to make specialised computing capacity available to organisations that would otherwise face considerable costs when developing or adapting AI systems.

However, infrastructure ownership does not necessarily provide complete technological independence.

European supercomputing projects continue to rely on internationally sourced semiconductor technology and specialised software.

Domyn itself has described a partnership with the American technology company Nvidia in its previous model-development work.

Consequently, European AI sovereignty is better understood as a question of control over important technological capabilities than complete separation from international supply chains.

Domyn’s Smaller Model Provides an Early Example

On 20 October, Domyn announced the initial release of Domyn Edge, a separate AI model containing four billion parameters.

According to the company’s technical announcement, the system was trained from scratch using approximately 13 trillion tokens on Europe’s Leonardo supercomputer.

Domyn has committed to making the model’s weights, training code, intermediate checkpoints and datasets available under open licences.

This approach is intended to improve reproducibility and allow external developers to examine how the model was constructed.

Domyn Edge is substantially smaller than the planned EUROPA system and should not be confused with it.

Nevertheless, the project provides an example of the company’s approach to developing AI models using European computing infrastructure.

Regulation Is Only Part of the Challenge

The EU has already established an extensive regulatory framework for artificial intelligence through the AI Act.

However, legislation governing the development and deployment of AI does not, by itself, create a competitive domestic technology industry.

Europe faces competition from American companies with substantial private investment, established cloud platforms and access to large commercial markets.

Chinese developers have also expanded their capabilities, including in open-weight AI systems.

EUROPA’s commercial prospects will therefore depend on more than technical performance.

European businesses must be willing to integrate the resulting technology into their operations, while developers will require dependable access to computing infrastructure and support services.

There is also the question of whether European institutions themselves will adopt domestically developed AI systems where they meet relevant security and performance requirements.

Without sufficient demand, even a technically successful model could struggle to establish a sustainable ecosystem.

The Test Will Be Commercial as Well as Technical

Domyn has indicated that it aims to release EUROPA during 2027, although public statements have differed over the precise timetable.

The company’s leadership has discussed a June target, while an earlier technical announcement referred to the second half of 2027.

The immediate challenge is completing development and demonstrating that the model can compete on performance, reliability and cost.

The longer-term challenge concerns adoption.

If European businesses and public institutions continue relying predominantly on foreign technology, access to an advanced European alternative may have only a limited effect on the market.

Conversely, a competitive and widely adopted open-source model could offer organisations greater control over deployment, customisation and sensitive information.

EUROPA is therefore more than a publicly supported technology experiment.

It is a test of whether Europe can convert research institutions, computing infrastructure and industrial expertise into AI products capable of competing in the international market.

The outcome will depend not simply on whether Europe can build an advanced model, but on whether organisations consider it sufficiently capable and economical to use.

The US Federal Communications Commission (FCC) proposed auctioning 25MHz of spectrum for satellite direct-to-device (D2D) services and terrestrial wireless networks.

The Notice of Proposed Rulemaking (NPRM) covers allocations in the 1675-1695 MHz and 2020-2025 MHz bands. The agency said the spectrum would help meet growing demand for D2D connectivity alongside traditional mobile services.

The FCC’s three commissioners unanimously backed the proposal, part of a broader effort by the administration of US President Donald Trump to clear up to 400MHz of spectrum for commercial use by 2028.

“We expect big interest in this seemingly modest amount of spectrum, indeed, similar D2D bands are selling for tens of billions of dollars on the secondary market today,” FCC chair Brendan Carr said. “Today’s proposal is a strong start.”

The move follows an AWS-3 spectrum auction which raised $3.5 billion. A further 160MHz of upper C-band spectrum is due to be auctioned by July 2027.

D2D framework
In a separate NPRM, the FCC proposed updating D2D licencing rules and sought public comment on opening nearly 482MHz across eight additional frequency bands for satellite-to-phone coverage.

The changes would remove geographic restrictions on spectrum leasing and routine waiver requirements. It also proposed updating technical standards and performance rules for networks combining terrestrial and satellite coverage.

The rules also advance reallocating portions of the 1675-1695 MHz band for non-federal fixed and mobile services. Mobile satellite services would receive secondary allocations in the band to provide supplemental coverage from space.

“With today’s proposal, we take our most comprehensive step yet to modernise the FCC’s rules for direct-to-device,” Carr said.

SpaceX and Amazon Leo are both developing planned D2D services and could benefit from the FCC’s proposals.

Separately, the commission adopted final rules removing a restriction on drone operations in the 800MHz cellular band. Carr said the change would make spectrum available for commercial and defence uses.

The commissioners unanimously approved the D2D rulemaking and the final drone rules.

The post FCC outlines plan to auction 25MHz of spectrum for D2D, mobile appeared first on Mobile World Live.