Johnson & Johnson received FDA clearance for Inlexzo, an intravesical gemcitabine-releasing device targeting Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer. The therapy offers a bladder-sparing alternative for patients resistant to immunotherapy, effectively eliminating tumors in 82% of trial participants. Designed for easy office insertion without anesthesia, Inlexzo represents a practice-changing advance in bladder cancer treatment. J&J projects blockbuster sales driven by improved outcomes and convenience.