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Approvals

Moderna, Merck, UroGen, Score RSV and Cancer Nods in June

The FDA delivered two notable approvals for RSV immunization, UroGen overcame a negative advisory committee vote to secure an approval in bladder cancer, and more key regulatory nods from the past month.

June 30, 2025

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9 min read

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Tristan Manalac

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Bladder cancer

UroGen’s Bladder Cancer Drug Wins FDA Approval Over Adcomm’s Objections

The FDA’s Oncologic Drugs Advisory Committee narrowly voted against the approval of Zusduri, citing the lack of a completely randomized study to back up the application.

June 13, 2025

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2 min read

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Tristan Manalac

Press Releases

UroGen Pharma to Report Second Quarter 2025 Financial Results on Thursday, August 7th, 2025

July 30, 2025

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1 min read

Press Releases

U.S. FDA Approves UroGen’s ZUSDURI™ (mitomycin) for Intravesical Solution as the First and Only Medication for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)