BEIJING, April 28 (Xinhua) -- A new drug for Alzheimer's disease developed by Chinese researchers has won approval from the U.S. Food and Drug Administration (FDA) to undergo clinical trials on patients overseas. Green Valley Pharmaceutical Co., Ltd, one of the drug's co-developers, put ...
"Today's milestone puts us one step closer to altering the course of this pandemic in the U.S.," she said. Moderna's COVID-19 vaccine is the second one in the United States to receive full approval from the FDA. Pfizer's COVID-19 vaccine, Comirnaty, was fully approved for use in...
The latest news regarding FDA applications, processes, and approval. This section contains releases regarding the Food and Drug Administration’s consideration of new products, drugs, therapies and treatments. Find announcements covering every stage of the FDA application process, from filing to eventual...
区别是：fda first time approval 指的是：美国食品和药品管理局首次批准。original approval指的是原批准。fda是“美国食品和药品管理局”的意思。二者在意思上有巨大差异。例句：first time approval 1、A Chinese vaccine company has for the first time won international regulatory approval for one ...
to FDA approval. 青云英语翻译 请在下面的文本框内输入文字,然后点击开始翻译按钮进行翻译,如果您看不到结果,请重新翻译! 翻译结果1翻译结果2翻译结果3翻译结果4翻译结果5 翻译结果1复制译文编辑译文朗读译文返回顶部 FDA的批准。 翻译结果2复制译文编辑译文朗读译文返回顶部...
The approval was based on the results of the ongoing randomized, double-blind placebo controlled, multi-regional, international, TOPAZ-1 (NCT03875235) study that reached its primary end point of median overall survival and showed promise in its secondary end points of progre...
WARNING LETTERCMS 535005December 19, 2017VIA UPS NEXT DAY AIRPaul F. Devine, CEOPresidentC.O. Truxton, Inc.136 Harding A
314 为FDA批准上市新药的申请APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG 315 诊断用放射性药品DIAGNOSTIC RADIOPHARMACEUTICALS 316 罕见病药ORPHAN DRUGS 320 生物利用度与生物等效性要求BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS 328 含有酒精的预期用于口部摄入的非处方药品OVER-THE-COUNTER DRUG PRODUCTS ...
除了针对儿童低级别神经胶质瘤(PLGG)外,Tovorafenib还与MEK抑制剂pimasertib联合用于治疗患有MAPK通路改变的复发性或进行性实体瘤的青少年和成人患者群体 (FIRELIGHT-1试验)。 参考来源: FDA grants accelerated approval to tovorafenib for pati...
The FDA has granted accelerated approval to ponatinib plus chemotherapy for adult patients with newly diagnosed Ph+ ALL.1 The approval is supported byefficacy data from the PhALLCON trialwhich included 245 adult patients with newly diagnosed Ph+ ALL who were randomized in a 2:1 fashion to recei...