Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for the LAG-3-blocking antibody relatlimab and nivolumab fixed-dose combination, administered as a single infusion, for the treatment of adult and...
药明康德官网等公开信息披露,美国FDA自2018年以来批准的化学药中,药明康德为其中16%提供了服务。 药明康德在2024中报里也披露,该公司在上半年所服务的小分子管线涵盖3319个分子,其中2825个处于临床前或临床1期,353个处于临床2期,74个处于临床3...
几项在2期试验中显示出前景的MM疗法,在3期研究中发现可降低OS,包括帕博利珠单抗、维奈克拉和melflufen。FDA批准的两种CAR-T产品均报告了早期死亡:Ide-cel组128例患者中有34例死亡(包括17例非骨髓瘤死亡),其中4例非骨髓瘤死亡发生在前6个...
fda725c56aedc7693b8cc6c6cabbc3c7 570 main/i18n/Translation-th.gz 6312312bd88e008b22a1a516cb55b92e 7622 main/i18n/Translation-nb.gz 7656757841b77d9cfb038d5de262e594 149326 main/i18n/Translation-el 2be426d48059fdc7473ee1d9a1d20b34 3027779 main/i18n/Translation-en 0c7d7dd22a0a61224b...
End points and United States Food and Drug Administration approval of oncology drugs. To summarize the end points used by the United States Food and Drug Administration (FDA) to approve new cancer drug applications over the last 13 years.The......
Results show that the performances of the system, the precision of the navigation and the positioning, the reliability and the practicability are improved.Hismanal, MMDFDC ReportsTransactions of Nanjing University of Aeronautics & Astronautics
According to FDA's information, there are 26 new drugs (20 new molecular entity drugs and 6 new biologic license application approvals) approved in Calendar Year of 2009. In this review, the aim is to provide an overview of the pharmacokinetics of these new molecular entity and new biologic...
2024年4月23日(美国时间),美国食药监局(FDA)加速批准Tovorafenib(RAF抑制剂)用于BRAF基因融合/重排或BRAF V600突变的6个月及以上复发或难治性儿童低级别胶质瘤患者。2这是首个获批用于BRAF融合/重排脑胶质瘤适应症的RAF抑制剂。(对于...
基于这一研究结果,美国FDA批准该联合疗法用于晚期黑色素瘤,成为首个获批的抗LAG-3药物。除了黑色素瘤之外,抗PD-1与抗LAG-3的双重阻断策略已在非小细胞肺癌、头颈鳞癌、结直肠癌等多种实体肿瘤中开展了广泛的临床试验,并均取得了令人鼓舞的...
BST02是百吉生物在研的一种使用患者自身免疫细胞的肿瘤浸润淋巴细胞 (TIL) 疗法,也是全球首款进入临床开发阶段的肝癌TIL疗法,于2月1日获得FDA快速通道认定,拟用于治疗所有形式的肝癌患者,包括肝细胞癌和胆管癌患者。 根据百吉生物公开资料介...