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UroGen Announces FDA Acceptance of the New Drug Application for UGN-103, an Investigational Treatment for Adults with Recurrent LG-IR-NMIBC

UroGen Pharma (URGN)UroGen PharmaFDA / regulatory

PRINCETON, N.J., Oct. 19, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced U.S. Food and Drug Administration (FDA) acceptance of the New Drug

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UroGen Pharma

Uro-Oncology Franchise UroGen Pharma develops and commercializes treatments for urothelial and other specialty cancers. Its approach combines local drug delivery with formulations intended to extend exposure within the urinary tract and provide non-surgical alternatives for patients with recurrent disease. Commercial ZUSDURI...

Recent company news

URGNUroGen Pharma2026-10-19 12:00 EST

UroGen Announces FDA Acceptance of the New Drug Application for UGN-103, an Investigational Treatment for Adults with Recurrent LG-IR-NMIBC

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URGNUroGen Pharma2026-08-17 12:00 EST

UroGen Submits NDA for UGN-103, an Investigational Treatment of Recurrent LG-IR-NMIBC

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35.01 USD
Market cap
1.29B USD
Exchange
NASDAQ
Sector
Biopharma
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United States