Biotech News

UroGen Announces FDA Clearance of the IND for UGN-501, an Investigational Next-Generation Oncolytic Virus for Non-Muscle Invasive Bladder Cancer

UroGen Pharma (URGN)UroGen PharmaFDA / regulatory

FDA clearance enables initiation of a planned Phase 1 clinical study evaluating local intravesical administration of UGN-501, with patient enrollment expected to begin in Q4 2026 UGN-501 is a differentiated investigational next-generation oncolytic virus designed to combine direct tumor cell

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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...

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