Johnson & Johnson MedTech has secured FDA approval for an expanded indication of the TRUFILL n-BCA Liquid Embolic System. This new approval allows for the treatment of chronic subdural hematoma (cSDH) via middle meningeal artery (MMA) embolization, offering a minimally invasive solution to significantly reduce the high recurrence rates associated with traditional surgery.
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.
The FDA has approved Amgen’s UPLIZNA for adults with generalized myasthenia gravis (gMG) who are anti-AChR or anti-MuSK antibody positive. UPLIZNA is the first and only CD19-targeted B-cell therapy approved for this indication, offering a convenient dosing schedule of just two maintenance doses per year following the initial loading regimen. The approval is based on strong efficacy data from the Phase 3 MINT trial.
Novartis has secured FDA approval for Itvisma (onasemnogene abeparvovec-brve), marking a historic milestone as the first gene replacement therapy for spinal muscular atrophy (SMA) available to children aged two and older, teens, and adults. This one-time intrathecal injection offers a “game-changing” new treatment option for patients previously ineligible for gene therapy.
The FDA has granted approval for PADCEV® plus KEYTRUDA® as a perioperative treatment for cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC). Clinical data reveals the combination reduces the risk of recurrence, progression, or death by 60% compared to surgery alone, marking a major shift in the standard of care.
Amgen’s groundbreaking drug IMDELLTRA has secured full FDA approval for extensive stage SCLC based on compelling Phase 3 data. It reduced the risk of death by 40%, offering a major advance for relapsed patients.
The U.S. FDA granted approval to KYGEVVI for treating adults and children with Thymidine Kinase 2 Deficiency (TK2d), an ultra-rare, life-threatening mitochondrial disease. Developed by UCB, KYGEVVI is the first and only approved therapy for TK2d, demonstrating a profound 86% reduction in the risk of death and significant improvement in motor function for patients with early-onset disease.
Eli Lilly has received FDA approval for a new single-injection maintenance dose of Omvoh (mirikizumab-mrkz) for adults with moderately to severely active ulcerative colitis. This approval simplifies the treatment regimen from two monthly injections down to just one, offering the same proven efficacy in a more convenient format. The new 200 mg/2 mL prefilled pens and syringes are expected to be available in the U.S. in early 2026.
Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Gazyva/Gazyvaro (obinutuzumab) for the treatment of adult patients with active lupus nephritis. Based on positive results from Phase II and III clinical trials, this new therapy offers a significant advancement for those suffering from this severe kidney complication of lupus, showing superiority over standard therapy alone.
Johnson & Johnson announces that the U.S. FDA has approved SIMPONI® (golimumab) for the treatment of moderately to severely active ulcerative colitis in children weighing at least 15 kg. This approval provides a new subcutaneous treatment option for younger UC patients.
