Tag: GSK

News Clinical Data Oncology Regulatory

GSK Secures Japan Orphan Drug Designation for Risvutatug Rezetecan in Small-Cell Lung Cancer

GSK - GlaxoSmithKline

GSK’s risvutatug rezetecan has officially secured Orphan Drug Designation from Japan’s MHLW for the treatment of small-cell lung cancer (SCLC). Supported by durable response data from the ARTEMIS-001 trial, this B7-H3-targeted antibody-drug conjugate aims to transform the prognosis for patients with extensive-stage disease, who currently face a median survival of just 8 months. This marks the sixth major global regulatory designation for risvutatug rezetecan, signaling its critical role in the future of oncology.

Business Healthcare & Pharmaceuticals News

GSK Completes $2.2 Billion Acquisition of RAPT Therapeutics for Food Allergy Innovation

GSK - GlaxoSmithKline

GSK plc announced on March 3, 2026, the completion of its previously announced GSK RAPT Therapeutics acquisition for approximately $2.2 billion, bringing a California-based clinical-stage biopharmaceutical company specializing in novel therapies for inflammatory and immunologic diseases into its portfolio.

Regulatory Approval Healthcare & Pharmaceuticals News

FDA Approves GSK’s Exdensur (depemokimab), the First Twice-Yearly Biologic for Severe Asthma

GSK - GlaxoSmithKline

The U.S. FDA has approved GSK’s Exdensur (depemokimab), a revolutionary ultra-long-acting biologic for severe eosinophilic asthma. As the first treatment of its kind to require only two doses per year, Exdensur promises to improve patient adherence and significantly reduce the frequency of life-threatening asthma attacks.

Regulatory Approval News Oncology

GSK’s Blenrep Gets U.S. FDA Approval for Multiple Myeloma Treatment

GSK - GlaxoSmithKline

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.

Clinical Trials News

Tebipenem HBr Shows Promise as First Oral Carbapenem for Complicated Urinary Tract Infections

GSK - GlaxoSmithKline

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.