The U.S. Food and Drug Administration (FDA) has granted approval to Johnson & Johnson’s Inlexzo, a drug-device combination delivering intravesical gemcitabine for non-muscle invasive bladder cancer patients unresponsive to immunotherapy. This approach offers a bladder-sparing alternative to cystectomy and showed tumor elimination in 82% of trial participants. Elsewhere, multiple regulatory actions including new submissions, clearances for oncology drugs and diagnostics, and guidance on non-opioid pain therapies have been announced. These regulatory milestones highlight progress toward expanding treatment options and refining clinical protocols for cancer and pain management.