Johnson & Johnson secured FDA approval for Inlexzo, an intravesical gemcitabine delivery system for treatment of Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ. The drug system provides localized chemotherapy release for up to three weeks and offers a non-surgical alternative to radical cystectomy. The approval followed successful Phase IIb trial data demonstrating an 82% complete response rate, with sustained effects over one year in over half of responders.