Johnson & Johnson received FDA approval for Inlexzo, a drug-device combination delivering gemcitabine intravesically to treat Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer. This treatment offers a bladder-sparing option for patients who previously faced bladder removal surgery. Clinical trials showed complete tumor response in 82% of patients, with over half maintaining response for a year, positioning Inlexzo as a potential practice-changing therapy.