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UroGen Pharma Submits NDA To FDA For Its Investigational Drug UGN-103 For Intravesical Solution

Aug 17, 2026 · 08:05 AM ET· updated 1h ago

UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the submission of a New Drug Application

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Why It Matters

UroGen Pharma asked the FDA permission to sell a new medicine for bladder cancer called UGN-103. When a company takes this big step, it shows they believe in their drug, so watch whether the FDA says yes or no—that will tell you if the medicine is ready to help patients and make money.

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Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.

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