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FDA accepts new drug application for UGN-103 in recurrent LG-IR-NMIBC
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Fusion42 · 19 October 2026 · Fusion42 review
The FDA has accepted the new drug application for UGN-103, a next-generation mitomycin formulation for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), with a PDUFA action date set for June 14, 2027. The application is supported by positive phase 3 trial results showing strong complete response rates and safe treatment tolerability.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it.
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The FDA is advancing new bladder cancer treatment options with UGN-103’s review; you in biotech must track this approval process closely as it could reshape treatment standards and open new competitive pathways.
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2 sources · 19 Oct 2026
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