GSK’s B7-H3-targeted antibody-drug conjugate, Risvutatug Rezetecan, has been granted Orphan Drug Designation by the US FDA for small-cell lung cancer (SCLC), based on promising early clinical data.
The FDA has approved GSK’s Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma. The decision, backed by the pivotal DREAMM-7 trial, introduces a new, accessible anti-BCMA treatment that significantly improved overall survival and progression-free survival compared to the standard of care. This milestone offers renewed hope for patients who have relapsed after at least two prior lines of therapy.
Positive data from GSK’s pivotal PIVOT-PO Phase III trial show that oral tebipenem HBr is a promising new treatment for complicated urinary tract infections (cUTIs), including pyelonephritis. The study, which was stopped early for efficacy, demonstrated that the oral antibiotic was non-inferior to the current standard of care, intravenous imipenem-cilastatin. These findings mark a significant step towards the first oral carbapenem for cUTIs, potentially changing the treatment landscape for patients and addressing the challenge of antimicrobial resistance.
GSK announced a major leadership transition, naming Chief Commercial Officer Luke Miels as its CEO-designate. He will formally take the helm on January 1, 2026, succeeding Dame Emma Walmsley and leading the company into a new strategic phase focused on specialty medicines and vaccines.
The US FDA has granted priority review to GSK’s new drug application for gepotidacin, a potential new oral treatment for uncomplicated urogenital gonorrhea.
The U.S. Food and Drug Administration (FDA) has given the green light to a new, prefilled syringe presentation of GSK’s highly effective shingles vaccine, Shingrix.
An application from GSK to increase the use of its very effective RSV vaccine, Arexvy, has been formally approved by the U.S. Food and Drug [Read More…]
GSK has finalized its acquisition of efimosfermin, a promising new therapeutic for steatotic liver disease. The deal, valued at up to $2 billion, positions GSK to potentially launch a best-in-class treatment for MASH and ALD by 2029, significantly enhancing its hepatology portfolio.
GSK has halted its Phase III PIVOT-PO trial early after an independent review confirmed tebipenem HBr met its primary efficacy goal in treating complicated urinary tract infections, marking a major step forward for oral antibiotic options.
GSK’s Blenrep combinations have been approved in Japan for treating relapsed or refractory multiple myeloma, following strong Phase III trial results demonstrating improved survival outcomes.
