mitomycin intravesical solution (UGN-103): FDA status

Under review FDA decision date Jun 14, 2027. Indication: Recurrent low grade intermediate risk non muscle invasive bladder cancer. Company: UroGen Pharma.

Regulatory history

• Oct 19, 2026: FDA accepted for review. FDA accepted NDA for UGN-103, an intravesical mitomycin solution using RTGel technology, for recurrent LG IR NMIBC; PDUFA date set for June 14, 2027. globenewswire.com
• Oct 19, 2026: Decision date set. FDA assigned a PDUFA target action date of June 14 2027 for UGN-103 alongside NDA acceptance. GlobeNewswire / UroGen Pharma press release
• Aug 17, 2026: Application filed. UroGen submitted an NDA to FDA seeking approval of UGN-103 for recurrent LG IR NMIBC. urologytimes.com

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