FDA在2021年获得了IMpassion131临床结果之后认定,atezolizumab无法获得常规批准,罗氏也随即撤回了这款药物针对乳腺癌的加速批准。EMA也进行了相似的操作。 加速批准基于的临床研究并不一定证据充分,而且也有可能是通过替代终点实现的。FDA此前要求申请者在获得加速批准之后继续开展上市后研究以确认疗法的有效性(也可能包括安...
timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as odronextamab for the treatment of relapsed/refractory (“R/R”) follicular lymphoma (including inthe United...
The target action date for the FDA decision is July 30, 2025, providing a clear timeline for potential approval and commercialization. The BLA resubmission demonstrates strong clinical support, with an overall response rate of 80% in pivotal Phase 1 and 2 trials, highlighting the ...
timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates (such as odronextamab, including any potential regulatory approval of odronextamab by the U.S. Food and Drug Administration (the “FDA”) based on the Biologics...
For complete product information, please see the Summary of Product Characteristics that can be found on www.ema.europa.eu.About FLFL is one of the most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). While FL is a slow...
原研机构 Regeneron Pharmaceuticals, Inc. 在研适应症 非在研适应症 SARS-CoV-2 S protein抑制剂 在研机构 Roche Products Ltd. 原研机构 Regeneron Pharmaceuticals, Inc. 在研适应症 新型冠状病毒感染 非在研适应症- 最高研发阶段批准上市 首次获批国家/地区 ...