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Tag: FDA

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FDA 正在权衡批准几十年来的第一种新型防晒成分

Medical FigureAsia -
美国食品药品监督管理局（Food and Drug Administration）目前正在权衡是否批准第一个新的 防 晒 霜 欧洲护肤品公司帝斯曼-芬美尼（DSM-Firmenich）本周宣布，几十年来美国市场的成分。帝斯曼-芬美意表示，预计 FDA 将在未来 17.5 个月内（即 2026 年 3 月）决定批准公司要求批准品牌为 PARSOL Shield 的防晒成分 bemotrizinol。 “PARSOL Shield 已在全球范围内安全使用超过 20...

FDA 表示，制药商将停止生产有争议的芬太尼棒棒糖

Medical FigureAsia -
美国食品药品监督管理局（Food and Drug Administration）本周表示，制药商已决定在本月底停止销售一种有争议的芬太尼止痛药，这标志着一个有争议的“芬太尼棒棒糖”品牌和其他配方的结束，这些配方被指责为助长了 阿片类药物过量流行. 这些药物（医生称之为经粘膜速释芬太尼或 TIRF 药物）在经过数十年的调查和 针对制药商的诉讼 该公司积极推销起效快、效果强效的止痛药。“截至本公告发布之日，接受 TIRF 药物治疗的患者不到 150 人，”FDA 在本周发表的一份声明中说。根据声明，目前正在服用其中一种药物的患者可以在供应可用的情况下继续治疗。 制药商 Cephalon 获得 FDA 的批准，可以销售这些药物，这些药物以前以 Actiq...

FDA 批准 Apple Watch 睡眠呼吸暂停检测工具

Medical FigureAsia -
苹果持有一周后 展示其新 iPhone 的活动、Apple Watch 和 AirPod 型号，美国食品和药物管理局已批准一项 Apple Watch 功能，可以检测设备佩戴者的睡眠呼吸暂停。睡眠呼吸暂停检测工具是在 Apple 新款 Series 10 手表发布日期前四天推出的，该手表将于 9 月 20 日发布。然而，从今天开始，那些拥有现有 Apple Watch Series 9...

前 FDA 专员 Scott Gottlieb 博士表示，美国“目前没有面临新 mpox 变体的风险”

Medical FigureAsia -
前 FDA 专员 Scott Gottlieb 博士表示，美国“目前没有面临新 mpox 变体的风险” - CBS News ...

前 FDA 专员斯科特·戈特利布 （Scott Gottlieb） 表示，推出新的 COVID 加强针的“时机差不多”

Medical FigureAsia -
前 FDA 专员斯科特·戈特利布 （Scott Gottlieb） 表示，推出新的 COVID 加强针的“时机差不多” - CBS 新闻 ...
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Indian edtech unicorn Vedantu reduces losses by 58%

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Australian Vault Cloud’s Series B financing raised US$14 million net

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