美国FDA优先受理吉利德预防HIV的新药申请
美国食品与药物管理局（FDA）周二表示，将优先受理 吉利德科学 公司（Gilead Science）一年两次Lenacapavir预防HIV的新药申请。
Trump Floats 25% Tariffs on US Auto, Drug, Chip Imports
President Donald Trump said he would likely impose tariffs on automobile, semiconductor and pharmaceutical imports of around ...
FDA firings spur deputy commissioner for human foods to quit
The Trump administration firings of employees at the U.S. Food and Drug Administration caused FDA Deputy Commissioner for ...
Teva Pharm CEO calls for faster US generic drug approvals
U.S. President Donald Trump's administration needs to speed up generic drug approvals and exempt some drugs from funding ...
US FDA approves GSK's combo meningococcal vaccine
The U.S. Food and Drug Administration approved British drugmaker GSK's combination vaccine to protect against meningococcal ...
US Health Department Layoffs Expand to Medicare, FDA
The Department of Health and Human Services laid off employees Saturday evening across some of its biggest agencies — the ...
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Head of FDA food division resigns over 'indiscriminate firing' of personnel
The head of the FDA's food division resigned Monday following what he called the "indiscriminate firing" of roughly 89 people, according to sources familiar with the matter.
Ex-Guatemalan congressman gets 18 years in U.S. prison in international drug trafficking ...
The U.S. Department of Justice says a former Guatemalan congressman was sentenced in the U.S. to 18 years in federal prison last week after pleading guilty to being involved in an international drug ...
Biodexa 获 FDA 家族性腺瘤性息肉病 eRapa 快速通道认证
美国食品药品监督管理局 (FDA) 已授予雷帕霉素胶囊 eRapa 快速通道资格，用于治疗家族性腺瘤性息肉病 (FAP)。 目前，FDA 尚未批准任何治疗 FAP 的药物，FAP 是一种以结肠和/或直肠息肉增生为特征的疾病。封装的雷帕霉素有望通过抑制 mTOR（哺乳动物雷帕霉素靶点）来阻止疾病进展，mTOR 是一种蛋白激酶，已证实在 FAP 息肉中过度表达。 这项快速通道认证是基于一项 2 期试验 ...