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 宣佈美國食品藥品管理局接受 UGN-103 的臨床申請，這是一種針對低等級中等風險非肌肉浸潤性膀胱癌的下一代基於絲裂黴素的配方
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 計劃在 2024 年啓動一項 3 期研究，探索 UGN-103 的安全性和有效性
預期的優勢包括新的80 mg絲裂黴素劑量，這可能會大大縮短生產過程，簡化重組程序，並有可能將知識產權保護延長至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...
致力於開發和商業化治療尿路上皮癌和特種癌症的新型解決方案的生物技術公司UroGen Pharma Ltd....
登入免費觀看全文
登入/註冊
譯文內容由第三人軟體翻譯。
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。