近日,百吉生物收到美国FDA正式书面回函,其第四条全球独家首创产品管线BST02注射液被授予“快速通道资格”(Fast Track Designation, FTD),用于治疗所有类型的肝癌(包括肝细胞癌和胆管癌)。 FTD快速通道资格的设立旨在促进或加速用于治疗严重或危及生命的疾病,且显示出有潜力满足当前未满足临床需求的药物开发,使药物能够快...
(医药健闻2024年6月13日讯)信达生物制药集团宣布其抗紧密连接蛋白18.2(CLDN18.2)抗体-依喜替康偶联物(ADC)IBI343获得美国食品和药物监督管理局(FDA)授予快速通道资格(fast track designation, FTD),拟定适应症为至少接受过一种系统性治疗的CLDN18.2表达阳性的晚期胰腺导管腺癌。此前,FDA已批准IBI343用于治疗该项适...
an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced that theU.S. Food and Drug Administration(FDA) has granted Fast Track designation (FTD) to EO...
SHR-A2102获得美FDA授予的快速通道资格(fast track designation,FTD) 4月18日晚间,恒瑞医药(600276)发布公告称,公司近日收到美国食品药品监督管理局(下称“FDA”)的认证函,公司项目注射用SHR-A2102获得美FD...
Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces that its self-developed novel ADC drug targeting Nectin-4 (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of ...
(FDA) has granted Fast Track Designation (FTD) to naporafenib in combination with trametinib (MEKINIST®) for the treatment of adult patients with unresectable or metastatic melanoma who have progressed on, or are intolerant to, an anti‑programmed death-1 (ligand 1) (PD‑(L)1)-based ...
新型CAR-T产品获FDA快速通道资格】近日,易慕峰生物宣布,其自主研发的靶向CLDN 18.2的自体CAR-T产品IMC002已获得美国FDA授予的快速通道资格(Fast Track Designation, FTD),用于治疗不可切除的局部晚期、复发或转移性CLDN 18.2阳性胃癌患者。 IMC002是一款基于高特异性VHH纳米抗体选择靶向CLDN18.2的自体CAR-T产品。这种...
About Fast Track Designation (FTD) The FDA Fast Track Designation (FTD) aims to promote the development of new drugs that treat serious illnesses and address major unmet medical needs. It was initially included in the FDA Modernization Act and later revised as part of the FDA Safety and Innova...
(Abbisko Therapeutics) today announced that its CSF-1R inhibitor pimicotinib(ABSK021)has been granted the fast track designation(FTD) by the U.S. FDA for the treatment of tenosynovial giant cell tumor (TGCT) patients that are not amenable to surgery. Previously, pimicotinib was granted the ...
SPRING HOUSE, Pa. (March 26, 2024)–Johnson & Johnsonannounced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for nipocalimab to reduce the risk of ...