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18 小时
on MSN
Seafood Recall Update As FDA Sets Risk Level
The seafood salad may be of particular risk to those customers who have an allergy or severe sensitivity to soy, the FDA has ...
6 小时
FDA专家组就1型糖尿病口服药物Sotagliflozin
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。
11 小时
US FDA declines to approve Applied Therapeutics' genetic disease drug
Applied Therapeutics said on Wednesday that the U.S. FDA declined to approve its drug to treat galactosemia, a rare genetic ...
15 小时
on MSN
FDA probes blood cancer risk from bluebird's gene therapy, weighs regulatory action
The U.S. Food and Drug Administration is weighing the need for a regulatory action on bluebird bio's gene therapy for a rare ...
2 天
on MSN
Vivek Ramaswamy’s crusade to change FDA could boost biotech, and himself
The co-leader of President-elect Donald Trump’s initiative to cut government spending has a financial stake in the biotech ...
2 天
FDA defeats lawsuit by lawyer vying to shield identity in inspection report
A judge has dismissed a lawsuit against the U.S. Food and Drug Administration by a lawyer who objected to being identified in ...
MedPage Today
11 小时
FDA Investigating Blood Cancer Risk With Gene Therapy Skysona
The FDA said on Wednesday that it is investigating reports of blood cancers -- including life-threatening cases of ...
1 天
Makary for FDA. Here’s what you need to know.
President-elect Donald Trump’s Friday night news dump of health care nominees included the expected naming of Dr. Marty ...
腾讯网
2 天
中华老字号京万红收到美国FDA警告信 系达仁堂全资子公司
11月19日,美国食药监局(FDA)官网发布了对 达仁堂 (600329.SH)全资子公司、中华老字号企业京万红的警告信。
腾讯网
2 天
特朗普FDA局长人选被视为主要盟友 Hims & Hers Health(HIMS.US)飙至新高
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 ...
19 小时
PTC Therapeutics以1.5亿美元出售FDA优先审查凭证
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。
2 天
新华制药碳酸司维拉姆原料药及其片剂双双获得美国FDA批准
碳酸司维拉姆还是目前唯一被美国食品药品监督管理局(FDA)批准的既不含钙、又不含其他金属的新一代磷结合剂,被国内外指南和规范一致推荐为降磷首选药物。该产品以离子交换方式吸附肠胃道中的磷酸,其结合物由粪便排出体外,无全身性吸收,安全性高。
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