Posted by Michael Wonder on 19 Dec 2019
UroGen Pharma announces FDA fling acceptance and priority review of U.S. new drug application for UGN-101
19 December 2019 - Potential for UGN 101 to be first non-surgical therapy for the treatment of low-grade upper tract urothelial cancer.
UroGen Pharma today announced the U.S. FDA accepted for filing and granted priority review for its new drug application for UGN-101 (mitomycin gel) for instillation as a potential treatment for patients with low-grade upper tract urothelial cancer.
The application is supported by the positive results from the pivotal Phase 3 OLYMPUS clinical trial.
