The FDA approved Johnson & Johnson’s Inlexzo, an intravesical gemcitabine-releasing device for patients with BCG-unresponsive, non-muscle invasive bladder cancer. The device delivers chemotherapy locally, sparing patients from radical cystectomy. Clinical trials demonstrated an 82% complete response rate, with over half sustaining remission for at least a year. This approval marks a significant therapeutic advancement in bladder cancer management and addresses a critical unmet need for bladder preservation strategies.