The close of 2025 highlighted the continuing momentum for the digital asset industry, with regulatory developments accelerating rather than slowing.

HM Treasury published  the statutory instrument ‘the Financial Services and Markets Act (Cryptoassets) Regulations 2026’ (SI. 2026 No 102) (FSMA (Cryptoassets))’. This instrument will amend the Financial Services and Markets Act (FSMA) and bring cryptoassets within the regulatory perimeter. Whilst the regulations will not go into effect until 25 October 2027, the FSMA (Cryptoassets) marks a key legislative shift. It will subject cryptoasset firms to similar standards as traditional financial institutions, meaning that firms will now be required to seek authorisation from the FCA if they engage in the new cryptoasset regulated activities. On 8 January 2026, the FCA provided further detail on its proposed “gateway,” the application process through which firms will seek authorisation to carry on newly regulated cryptoasset activities under the UK’s forthcoming regime. A dedicated application window is planned to open on 30 September 2026, allowing the FCA to assess applications ahead of the new authorisation regime coming into force.

In this piece, we provide a detailed analysis of what this new gateway means for firms, and how they can take advantage of this early application period. Firms that apply during this application window are expected to undergo a smoother transition into the new regulatory sphere and will retain the full set of rights and allowances for conducting cryptoasset activities. Those applying after this period will face more limited permissions, with the scope of authorised activities varying depending on when their application is submitted. While the FCA has not yet outlined the detailed requirements of the application itself, its latest guidance provides a clear picture of what the transition period will involve for cryptoasset firms.

On January 27, 2026, the U.S. Department of Health and Human Services Office of Inspector General (the OIG) issued a Special Advisory Bulletin (the Bulletin) addressing the application of the federal anti-kickback statute (the AKS) to direct-to-consumer (DTC) prescription drug sales. 

The Bulletin, the OIG’s first Special Advisory Bulletin since September 2014, was issued in response to the proliferation of DTC programs. The Bulletin, which sets forth the framework under which a manufacturer’s DTC program presents a low risk of violating the AKS, is viewed by the growing DTC industry as favorable guidance. DTC programs offering modern weight-loss medications, such as GLP-1 drugs, are becoming increasingly popular, and the Bulletin provides a helpful framework to support the viability of these programs.