尽管不受委员会建议的约束，但 FDA 在做出批准决定时会考虑这些建议。预计将于 2024 年 12 月 20 日做出监管决定。如果获得批准，索他格列净将成为首个用于治疗 1 型糖尿病患者的口服药物。

Applied Therapeutics said on Wednesday that the U.S. FDA declined to approve its drug to treat galactosemia, a rare genetic ...

The seafood salad may be of particular risk to those customers who have an allergy or severe sensitivity to soy, the FDA has ...

The U.S. Food and Drug Administration is weighing the need for a regulatory action on bluebird bio's gene therapy for a rare ...

The co-leader of President-elect Donald Trump’s initiative to cut government spending has a financial stake in the biotech ...

Here's a list of what was pulled from stores in November 2024. The FDA removed the following items from store shelves in ...

President-elect Donald Trump’s Friday night news dump of health care nominees included the expected naming of Dr. Marty ...

The FDA said on Wednesday that it is investigating reports of blood cancers -- including life-threatening cases of ...

对于Lexicon来说，曾经的辉煌似乎还历历在目，然而随着市场的冷酷与FDA的接连打击，Lexicon不得不在一系列低迷的业绩中重新审视方向。其推出的胰岛素补充剂候选药物Zynquista（sotagliflozin）就经历了一次又一次的申请波折。这 ...

智通财经APP获悉，亨特布鲁克传媒公司(Hunterbrook Media)表示，Hims & Hers Health(HIMS.US)将成为当选总统唐纳德·特朗普提名马蒂·马卡里(Marty ...

格隆汇11月28日丨华东医药(000963.SZ)公布，2024年11月28日，华东医药股份有限公司全资子公司杭州中美华东制药有限公司(以下简称“中美华东”)收到美国食品药品监督管理局(以下简称“美国FDA”)通知，由中美华东申报的HDM1005注射 ...

PTC Therapeutics决定以1.5亿美元出售其罕见儿科疾病优先审查凭证，与公司的财务状况和市场表现相一致。根据InvestingPro数据，PTC Therapeutics的市值为35.5亿美元，反映了其在生物制药行业的重要地位。