The FDA granted approval for Johnson & Johnson’s Inlexzo, an intravesical device releasing gemcitabine for patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. Clinical trials demonstrated an 82% complete response rate with half maintaining response for at least one year. The device offers patients an alternative to bladder removal surgeries, administered in outpatient settings without anesthesia, and represents a practice-changing innovation in bladder cancer treatment.