FDA accepts UroGen’s drug application for bladder cancer
UroGen Pharma (URGN) announced the FDA accepted its New Drug Application for UGN-103, a treatment for recurrent low-grade bladder cancer. The FDA set a target review date of June 14, 2027. The application is supported by Phase 3 trial data showing a 77.8% complete response rate at three months. UroGen holds U.S. patents for the drug through July 2044.


