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Cancer Network
Original article

<![CDATA[FDA Accepts NDA for UGN-103 in Recurrent Low-Grade Intermediate-Risk NMIBC]]>

NDA FilingUGN-103Positive
AI Analysis

Summary

The FDA accepted the NDA for UGN-103 for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer and assigned a PDUFA date of June 14, 2027.

Outcome Details

FDA accepted the NDA for UGN-103 and assigned a PDUFA date of June 14, 2027.

Importance:6/10
Sentiment:
0.40
NDA acceptancePDUFANMIBCbladder canceroncologyFDA

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Published by Cancer Network on October 19, 2026 2:30 PM

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