FDA Accepts UroGen’s UGN-103 Application for Review
The FDA accepted UroGen Pharma’s new drug application for UGN-103, an investigational treatment for adults with recurrent LG-IR-NMIBC.
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12:04:38 PM UTC
SquawkNews
UroGen Pharma Ltd. announced FDA acceptance of its NDA for UGN-103 to treat recurrent LG-IR-NMIBC, with a PDUFA target action date of June 14, 2027. The filing is supported by data from the ongoing Phase 3 UTOPIA trial.Material DetailsContext by AI AnalystThis is an early regulatory milestone advan…