Johnson & Johnson received FDA approval for Inlexzo (formerly TAR-200), a drug-device combination that delivers gemcitabine directly into the bladder for patients with BCG-unresponsive, non-muscle invasive bladder cancer. This therapy offers a bladder-sparing alternative to surgical removal and has demonstrated tumor elimination in 82% of trial participants, with durable responses in half for over one year. The device, inserted via catheter in outpatient settings, represents a new treatment paradigm for difficult-to-treat bladder cancer.