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.
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.
The European Commission has officially approved AstraZeneca’s Tezspire (tezepelumab) for adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP). This new add-on therapy offers hope for patients whose condition is uncontrolled by standard treatments, demonstrating efficacy in reducing polyp size, alleviating congestion, and decreasing the need for surgery.
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.
In a major breakthrough for oncology, the U.S. FDA has approved a new combination therapy from Roche for a highly aggressive form of lung cancer. The treatment, which combines Tecentriq® (atezolizumab) and lurbinectedin (Zepzelca®), is the first of its kind for the maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC). Clinical trial results show the regimen significantly reduces the risk of disease progression and death, offering new hope and a pivotal shift in how this challenging disease is managed post-chemotherapy.
The U.S. Food and Drug Administration (FDA) has given approval to TREMFYA® (guselkumab) for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in children. This groundbreaking approval makes TREMFYA® the first and only IL-23 inhibitor available for pediatric patients, offering a new ray of hope for thousands of children affected by these chronic conditions.
