The third week of May 2024 brought significant regulatory advancements in both the United States and the United Kingdom, reflecting an international drive toward faster, more efficient healthcare innovation. In the U.S., the Food and Drug Administration (FDA) granted multiple accelerated approvals for promising therapies targeting complex and previously underserved conditions. Simultaneously, the UK’s National Health Service (NHS) and the National Institute for Health and Care Excellence (NICE) initiated a transformative consultation process aimed at improving the integration of medical technologies across the public healthcare system.
On May 15, the FDA approved lisocabtagene maraleucel for the treatment of follicular lymphoma. This CAR T-cell therapy represents a novel approach to managing one of the most common types of non-Hodgkin lymphoma, offering new hope to patients who have exhausted other treatment options. The next day, May 16, saw the approval of tarlatamab-dlle, a bispecific T-cell engager designed to treat extensive-stage small cell lung cancer—a particularly aggressive and difficult-to-treat cancer subtype.
In a separate but equally notable move, the FDA provided accelerated approval for selpercatinib, a highly selective RET kinase inhibitor, for use in metastatic pediatric thyroid cancer. Although the announcement was made later on May 29, it reflects regulatory activities that were in process during the week of May 15–21. This decision expands the therapeutic landscape for young patients facing a rare and challenging cancer diagnosis.
Additionally, on May 20, the FDA lifted a partial clinical hold on Larimar Therapeutics’ nomlabofusp development program, which targets Friedreich ataxia, a debilitating rare neurological disorder. This regulatory green light enables the resumption of clinical trials and represents a critical step forward in the search for effective treatments for rare diseases.
Across the Atlantic, NHS England and NICE launched a 12-week public consultation on May 23, focused on accelerating the adoption of MedTech innovations within the NHS. The proposed fast-track process aims to shorten the time from regulatory approval to patient access for new devices and technologies. The consultation will explore ways to optimize assessment methodologies and reduce administrative barriers, potentially transforming how new medical technologies are integrated into patient care.
Together, these developments underscore a global commitment to speeding up access to advanced therapies and medical technologies. Whether through groundbreaking cancer treatments or streamlined technology implementation, healthcare systems are signaling a new era of rapid innovation and patient-centered care.
