17/07/2025 Johnson & Johnson received Priority Review for TAR-200 from the US FDA in high-risk non-muscle invasive bladder cancer (Ref) The US FDA granted Priority Review to Johnson & Johnson's NDA filed for TAR-200 (intravesical gemcitabine releasing system) for the treatment of BCG-unresponsive, high-risk NMIBC with carcinoma in situ (CIS), with or without papillary tumors. The filing was based on results from the Phase 2b SunRISe-1 trial which demonstrated a CR of 82.4% wi