UroGen Announces FDA Acceptance Of IND Application For UGN-103, A Next Generation Mitomycin-Based Formulation For Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
UroGen Announces FDA Acceptance Of IND Application For UGN-103, A Next Generation Mitomycin-Based Formulation For Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
UroGen 宣布美国食品药品管理局接受 UGN-103 的临床申请，这是一种针对低等级中等风险非肌肉浸润性膀胱癌的下一代基于丝裂霉素的配方
UroGen plans to initiate a Phase 3 study to explore the safety and efficacy of UGN-103 in 2024
Anticipated advantages include a new 80 mg mitomycin dosage strength that may considerably shorten the manufacturing process, simplify the reconstitution procedure, and potentially extend intellectual property protection until as late as December 2041
UroGen 计划在 2024 年启动一项 3 期研究，探索 UGN-103 的安全性和有效性
预期的优势包括新的80 mg丝裂霉素剂量，这可能会大大缩短生产过程，简化重组程序，并有可能将知识产权保护延长至2041年12月
UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced the U.S. Food and Drug Administration (FDA) accepted the Company's Investigational New Drug (IND) application for UGN-103, a next-generation novel mitomycin-based formulation for low-grade intermediate...
致力于开发和商业化治疗尿路上皮癌和特种癌症的新型解决方案的生物技术公司UroGen Pharma Ltd....
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