Two new therapies are now FDA approved to treat the sexually transmitted infection gonorrhea, with Innoviva Inc.’s Nuzolvence (zoliflodacin) and GSK plc’s Blujepa (gepotidacin) offering additional antibiotic options comparable to standard of care. Both products had fast track, qualified infectious disease product and priority review designations.
Cycle Group Holdings Ltd. is buying Applied Therapeutics Inc. for a small fraction of the company’s value when it went public in 2019. Cycle is paying $0.088, nearly 9 cents, in cash per share plus a contingent value right (CVR).
Experience gained in the Asia-Pacific region is helping shape the Menarini Group’s global strategy as the Italian pharmaceutical company looks to emerging markets to drive long-term, sustainable growth.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) is joining the U.S. FDA and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) in approving Anktiva (nogapendekin alfa inbakicept-pmin) in patients with non-muscle invasive bladder cancer (NMIBC) who have not responded to immune stimulation treatment with Bacillus Calmette-Guérin (BCG) vaccine and would otherwise require surgical removal of the bladder.
Arcus Biosciences Inc. and partner Gilead Sciences Inc. are scrapping phase III work with anti-TIGIT antibody domvanalimab after an independent data monitoring committee said the drug will fail in gastric and esophageal cancers.
The cardiomyositis that is a rare adverse effect of mRNA-based COVID vaccines is due to immune cell activity as a result of increased levels of the chemokines CXCL10 and interferon-γ (IFN-γ). Blocking CXCL10 and IFN-γ could prevent muscle cell damage in cell culture, and cardiomyositis in animal models. The findings, reported in the Dec. 10, 2025, issue of Science Translational Medicine, suggest a way of mitigating the risk of cardiomyositis.
Restricting the recommended use of COVID-19 vaccines in the U.S. wasn’t enough. Now the Children’s Health Defense (CHD) is trying to get the FDA to revoke the BLAs for all versions of the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 vaccines.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Ajax, Amneal, Beren, Boehringer, Fondazione, GSK, Kane, Sagimet, USAntibiotics.