Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Achieve, Carsgen, Exeltis USA, Incyte, Masimo, Merz, Moderna, Novo Nordisk, Praxis, Regeneron, Sanofi, Sumitomo, Teijin, Tetmedical, Teva, Viiv.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Bioarctic, Colospan, Eli Lilly, Galmed, Haisco, Nuvectis, Parexel.
Clinical updates for biopharma and med tech, including data readouts and publications: Definium, Eledon, Exelixis, Gondolabio, Imperative, Kither, Maplight, Merck, Moonlake, Taysha, Tscan, Uniqure, Xeos.
The U.S. FDA approved 24 drugs in May 2026, the busiest month of the year so far. Up from April’s 14, it brings the year-to-date total to 84 approvals. Through May, the agency has cleared 20 new molecular entities, a pace that, if sustained, would put 2026 on track to approach or exceed several recent years.
The industry is stepping up its campaign to persuade European governments to increase their drugs budgets, in what is described as a landmark report making the case that spending on patented drugs is not a cost to be contained, but an investment in health and the economy.
With increasing competition from China and other countries, the U.S. Department of Health and Human Services is rolling out Operation Trailblazer, a department-wide strategy to once again make the U.S. the go-to destination for early stage drug development.
China’s National Medical Products Administration approved Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid tumors. The autologous Claudin18.2-targeted CAR T was approved for patients with Claudin18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma who have failed at least two prior lines of therapy.
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