Posted by Michael Wonder on 15 Aug 2024
UroGen submits completed UGN-102 NDA seeking approval as the first FDA approved treatment for low grade intermediate risk non-muscle invasive bladder cancer
14 August 2024 - UroGen Pharma today announced the successful completion of its new drug application submission for investigational drug UGN-102, (mitomycin) for intravesical solution, a significant step forward in potentially addressing the urgent need for innovative treatments for low grade intermediate risk non-muscle invasive bladder cancer.
UroGen anticipates potential FDA approval in early 2025, if the new drug application is accepted for filing by the FDA and priority review is granted.
