美国食品和药物管理局批准了针对大肠杆菌感染的SNIPR001研究性新药申请
SNIPR...
欧盟批准:Lumykras用于治疗晚期NSCLC患者
欧盟委员会(EC)已经授予安进公司的LUMYKRAS(sotorasib)有条件上市授权,用于治疗成人KRAS G12C突变的晚期非小细胞肺癌(NSCLC)。NSCLC是全球领先的肺癌诊断,包括腺癌、鳞状细胞癌和大细胞癌。KRAS蛋白的突变是NSCLC中最普遍的突变,几乎只在腺癌患者中发现,而腺癌是最常见的肺癌类型。该药物LUMYKRAS(sotorasib)是一种口服的KRAS...
美国食品和药物管理局批准了一项补充新药申请:REXULTI可用于治疗小儿精神分裂症
...
欧盟委员会:用于治疗AML的ASTX727孤儿药指定项目
欧盟委员会(EC)已经授予Astex...
美国食品和药物管理局的RMAT批准:Posoleucel可治疗腺病毒(AdV)
美国食品和药物管理局(FDA)已授予AlloVir的posoleucel(Viralym-M,...
IND批准:CStone Pharma的CS5001 ADC瞄准ROR1
...
ABOUT US
CSOFT Health Sciences has over 15 years of experience providing end-to-end translation and localization solutions for all stages of the product life cycle, from pre-clinical to post-launch. We also specialize in China market access consulting services, Asian regulatory and eCTD submissions. Our operation is compliant with ISO 17100 and certified by BSI in ISO 9001:2015 and ISO 13485:2016, providing customized solutions to meet the rigorous regulatory requirements in global submission. For more information, please visit: www.csoftintl.com