Regulatory & Policy Updates

WASHINGTON, 4 March 2026: AdvaMed said the U.S. Senate has approved legislation to reauthorize the federal Small Business Innovation Research and Small Business Technology Transfer programs, and the association called on the House of Representatives to move quickly on passage. The medtech trade group said the vote matters because authorization for the two programs lapsed on 30 September 2025, leaving early-stage medical technology companies without the certainty they need as they pursue product research and development.

SHERIDAN, WYOMING - April 4, 2026 - Network vendors, radio access technology teams, and standards-track engineers now have a concrete architectural reference for building sensing capabilities directly into 6G systems, as ETSI's Industry Specification Group on Integrated Sensing and Communications has released GR ISC 003-a report that defines the structural foundations required to merge RF sensing with cellular communications at the system and RAN levels.

SHERIDAN, WYOMING - March 31, 2026 - Early-stage medtech companies could regain a key non-dilutive funding route in 2026 after the Senate passed legislation to reauthorize the federal Small Business Innovation Research and Small Business Technology Transfer programs, reducing uncertainty that has persisted since the programs' authorization lapsed on September 30, 2025. AdvaMed said the Senate action restores momentum for grants that support early research and development at startups and small manufacturers, and it urged the House of Representatives to move quickly on passage. The association framed the programs as an important bridge for companies that struggle to finance next-generation device development before products reach patients or later-stage commercial milestones.

SHERIDAN, WYOMING - March 31, 2026 - Energy traders, compliance teams and market surveillance leaders in Europe face a more direct enforcement environment in 2026 as ACER sets the procedural framework for cross-border REMIT investigations and advances new reporting guidance under the revised regime. The 43rd edition of ACER's REMIT Quarterly centers on new Rules of Procedure for cross-border investigations, a practical step after EU legislators updated the REMIT framework in 2024 and gave ACER additional tasks, including the power to investigate cross-border cases. The quarterly also outlines ACER's stakeholder engagement plan for 2026, ongoing preparatory work on data reporting pending finalisation of the revised REMIT Implementing Regulation, and market surveillance updates tied to wholesale energy market integrity across the EU.

SHERIDAN, WYOMING - March 31, 2026 - Danish gas tariff decisions in 2026 face a more demanding transparency test, with direct implications for how shippers, storage users and regulators evaluate network charges tied to upstream infrastructure. ACER's latest report reviews Energinet's proposed reference price methodology under the EU Network Code on Harmonised Transmission Tariff Structures and finds that while several core design elements align with the rules, the cost treatment of the upstream Baltic Pipe section cannot yet be fully assessed because key detail is missing.

SHERIDAN, WYOMING - December 30, 2025 - Public Service Enterprise Group (PSEG) says New York State's comptroller has granted final approval for an extension of PSEG Long Island's operations services agreement with the Long Island Power Authority (LIPA), locking in continued grid-operations responsibilities through the end of 2030.

Contract extension now fully cleared

PSEG said the LIPA Board of Trustees awarded PSEG Long Island a five-year extension of the existing contract on September 25, followed by approval from the New York State attorney general in October and final approval from the comptroller this week. The extension begins January 1, 2026, and runs through December 31, 2030. PSEG Long Island has operated the electric grid on behalf of LIPA since 2014, covering Long Island and the Rockaways.

SHERIDAN, WYOMING - December 19, 2025 - Eli Lilly's experimental daily oral obesity medicine orforglipron posted Phase III data suggesting it can help patients maintain weight loss after long-term treatment with injectable GLP-1 therapies-an outcome with direct implications for adherence, payer strategy, and competition with Novo Nordisk's coming oral semaglutide filing.

SHERIDAN, WYOMING - December 19, 2025 - Merck said the EMA's CHMP has recommended approval of an expanded European indication for WINREVAIR (sotatercept) in adults with pulmonary arterial hypertension (PAH), a move that-if confirmed by the European Commission-could broaden use to include WHO Functional Class (FC) IV patients and strengthen the product's positioning around morbidity and mortality benefit.

SHERIDAN, WYOMING - December 19, 2025 - Merck Animal Health says the U.S. Food and Drug Administration (FDA) has granted conditional approval for EXZOLT™ CATTLE-CA1 (fluralaner topical solution), positioning the pour-on as a new systemic parasiticide option for U.S. beef operations and replacement dairy heifers facing New World screwworm (Cochliomyia hominivorax) larvae (myiasis) risk and cattle fever tick (Rhipicephalus microplus) pressure.

SHERIDAN, WYOMING - December 19, 2025 - The FDA is considering awarding Commissioner's National Priority Vouchers to two investigational Merck programs-PCSK9 pill enlicitide decanoate and antibody-drug conjugate sacituzumab tirumotecan-an early signal that the agency may be willing to accelerate reviews for high-impact products even before formal filings, according to a Reuters report.

A new FDA lever that can reshape launch timing
Commissioner's National Priority Vouchers are designed to shorten the FDA's regulatory review window from the typical 10-12 months to 1-2 months. For large pharma, that time compression can meaningfully shift competitive dynamics-pulling forward commercialization, altering payer and guideline sequencing, and increasing the urgency of manufacturing readiness, launch supply, and field execution.