Johnson & Johnson has secured European Commission approval for Imaavy (nipocalimab), a novel treatment for generalized myasthenia gravis (gMG). This authorization marks the first FcRn blocker approved in Europe for a broad population that includes both adults and adolescents (aged 12+), offering a new option for sustained disease control.
Novo Nordisk has announced positive headline results from a Phase 2 clinical trial for its investigational drug, amycretin, showcasing its potential to be a next-generation [Read More…]
New long-term data from the Phase 3b APEX study confirms that TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to substantially inhibit the progression of structural joint damage in patients with active psoriatic arthritis, with results sustained through 48 weeks.
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.
Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA for STELARA® (ustekinumab) to treat children aged two years and older with moderately to severely active ulcerative colitis. The filing is supported by data from the Phase 3 UNIFI Jr clinical trial, aiming to address the significant unmet needs for this pediatric patient population.
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.
New 96-week data from the Phase 3 GALAXI and GRAVITI studies show high rates of sustained remission for TREMFYA® (guselkumab) in Crohn’s disease. At two years, over 86% of patients on maintenance doses achieved clinical remission, reinforcing its long-term efficacy as the only fully subcutaneous IL-23 inhibitor for the condition.
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.
Eli Lilly and Company announced a significant milestone for Omvoh (mirikizumab-mrkz), which is now the first and only IL-23p19 antagonist to demonstrate four years of sustained, corticosteroid-free comprehensive patient outcomes for individuals living with ulcerative colitis (UC).
