Johnson & Johnson received U.S. Food and Drug Administration approval for Inlexzo, a drug-device combination that delivers gemcitabine intravesically to treat Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer with carcinoma in situ. The therapy offers patients an alternative to radical cystectomy by providing extended local chemotherapy delivery within the bladder. Clinical trials demonstrated an 82% complete response rate, with about half maintaining response for a year. The approval followed Breakthrough Therapy designation and Priority Review status.