2023年9月4日,罗氏宣布FDA已接受crovalimab的BLA,如果获得批准,crovalimab将成为首款治疗PNH的每月仅需用药一次的皮下制剂疗法,并且患者可自行给药。 此次BLA是基于关键的III期COMMODORE 2研究结果:在PNH患者中,Crovalimab在溶血控制的共同主要终点中不劣于eculizumab,实...
参考文献: 1.PTC Therapeutics Announces FDA Acceptance and Priority Review of the BLA for Upstaza™. PTC Therapeutics Press Release. 14. 05. 2024. 2.Zanidatamab Granted Priority Review for HER2-Positive Metastatic Biliary Tract Cancer. Jazz Pharmaceu...
rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application
5. Failure to retain the accompanying records with the HCT/Ps at all times following a donor eligibility determination including a statement whether, based on the results of screening and testing, the donor has been determined to be eligible or ineligible; and a summary of records used to make...
According to the PDUFA legislation, in exchange for collection of user fees, the FDA is legally obliged to “review and act on” NDA/BLA submissions, but not necessarily approve them more rapidly. Congress renewed the 1992 PDUFA legislation under the Food and Drug Modernization Act of 1997 (PD...
FDA即将对礼来/信达(Innovent)的PD-1抑制剂sintilimab(信迪利单抗)针对非鳞状非小细胞肺癌的BLA申请举办咨询委员会审评。该BLA由礼来与中国公司信达合作提交,数据基于仅在中国进行的III期研究。2022年2月10日肿瘤药物咨询委员会(ODAC)将讨论该申请。 针对礼来/信达BLA申请的ODAC会议对于其它依赖中国数据的正在开发的...
New PDUFA date after BLA resubmission expected December 28, 2024. CRL issued on December 18, 2023. 100 100 Vote 11/15/2024 ET Upgrade Your Account 7 Day Free Trial Access Hundreds of Catalysts Access Additional Calendars Detailed Financials ...
数据来源:CDER Approval Times for Priority and Standard NDAs and BLAs Calendar Years 1993–2016 注: (1)从2004财政年度(2003年10月1日)开始,CDER开始审评从CBER转移过来的部分治疗用生物制品; (2)从PDUFAV执行—2013财政年度(2012年10月1日)开始,NMENDA和BLA按 theprogram for enhanced review transparency...
E7777 is an engineered interleukin-2-diphtheria toxin fusion protein that is a purified and more bioactive formulation of Ontak, which the agency previously approved.
The agency’s decision data for the investigational factor VIII therapy from Sanofi and Soba is set for February 28, 2023. The FDA accepted the biologics license application (BLA) for efanesoctocog alfa (BIVV001; Sanofi, Sobi) for the treatment of hemophilia A for priority review. E...