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20 avr. 2026 19h00 HE | Source: Essential Pharma

Essential Pharma 旗下公司 Renaissance Pharma Limited 用于治疗高危神经母细胞瘤的 Daretabart (hu1418K322A) 获得 FDA 快速通道认定，并通过 IND 审评

FDA 授予 Daretabart (hu1418K322A) 快速通道认定资格，以解决高危神经母细胞瘤领域存在的重大未满足医疗需求，允许该药物进入加速评审和滚动审评流程FDA 通过新药临床研究 (IND) 申请后，即可在高危神经母细胞瘤复发及难治性患者中启动 SHINE II/III 期临床试验Daretabart (hu1418K322A) 第一个商业化规模 GMP...
14 avr. 2026 02h00 HE | Source: Essential Pharma

Renaissance Pharma Limited, an Essential Pharma company, secures FDA Fast Track Designation and IND clearance for Daretabart (hu1418K322A) in high-risk neuroblastoma

FDA grants Fast Track Designation for Daretabart (hu1418K322A), recognising the significant unmet medical need in high-risk neuroblastoma and enabling access to accelerated and rolling reviewFDA...
17 févr. 2026 07h00 HE | Source: Essential Pharma

Essential Pharma strengthens rare disease portfolio with acquisition of Ventavis® (iloprost trometamol) for adult primary pulmonary hypertension

Ventavis® is an established inhaled prostacyclin analogue for the treatment of primary pulmonary hypertensionAcquisition reinforces Essential Pharma’s mission to serve the needs of rare disease...
01 août 2023 07h00 HE | Source: Renaissance Pharma

Renaissance Pharma launches today and announces the in-licensing of Hu14.18K322A (Hu14.18) from St. Jude Children’s Research Hospital for the treatment of High-Risk Neuroblastoma

Press Release Renaissance Pharma launches today and announces the in-licensing of Hu14.18K322A (Hu14.18) from St. Jude Children’s Research Hospital for the treatment of High-Risk Neuroblastoma ...
01 août 2023 03h00 HE | Source: Renaissance Pharma

Renaissance Pharma launches today and announces the in-licensing of Hu14.18K322A (Hu14.18) from St. Jude Children’s Research Hospital for the treatment of High-Risk Neuroblastoma

Press Release Renaissance Pharma launches today and announces the in-licensing of Hu14.18K322A (Hu14.18) from St. Jude Children’s Research Hospital for the treatment of High-Risk Neuroblastoma ...