Johnson & Johnson secured FDA approval for Inlexzo, an intravesical gemcitabine-releasing device for non-muscle invasive bladder cancer patients unresponsive to BCG immunotherapy. The system delivers chemotherapy directly to the bladder over extended periods, offering an alternative to bladder removal surgery. Clinical trials showed an 82% complete tumor response with over half maintaining remission one year. This approval adds a novel, minimally invasive treatment option addressing a critical unmet need in urothelial cancer management.