2024年11月19日，中美瑞康（Ractigen Therapeutics）宣布其自主研发的FUS基因靶向小干扰RNA（siRNA）疗法RAG-21，成功获得美国食品药品监督管理局（FDA）授予的孤儿药资格（Orphan Drug ...

Singulair, a popular asthma medication, could be linked to severe side effects, including suicide, a study from the FDA found ...

While no illnesses have been reported, the company has initiated the recall as a precautionary measure to ensure consumer and ...

Makary and Weldon, who have criticized the agencies they may soon run, were joined by Janette Nesheiwat, Trump’s pick to be ...

The behavior of montelukast appears similar to other drugs known to have neuropsychiatric effects, such as the antipsychotic ...

U.S. president-elect Donald Trump has nominated surgeon and writer Martin Makary to lead the Food and Drug Administration, ...

就在全球目光聚焦美国政治风云之际，一条重磅消息再次引发广泛关注。当地时间11月22日，美国当选总统特朗普宣布提名约翰斯·霍普金斯大学外科医生及作家马蒂·马卡里出任其就任总统后的美国食品药品监督管理局（FDA）局长。这究竟是一个怎样的人选？背后又隐藏着怎样的深意？

President-elect Donald Trump has nominated a critic of COVID-19 health measures to lead the Food and Drug Administration.

The U.S. Food and Drug Administration has approved BridgeBio's drug for a rare and deadly heart condition, the company said ...

近日，据《SupplySide Supplement Journal》报道，FDA（美国食品监管局）将全面解禁NMN市场销售，并宣布将在2025年7月31日前对这款“青春丹”重新做出判决。

01 强生已向美国FDA提交补充生物制品许可申请 (sBLA)，寻求批准抗IL-23抗体Tremfya (guselkumab)作为皮下注射诱导方案，治疗中度至重度活动性溃疡性结肠炎 (UC)的成人患者。

维立志博首席医学官蔡胜利博士表示："此前LBL-024已经取得了CDE突破性疗法认定，用于治疗晚期肺外神经内分泌癌，此次再获FDA孤儿药资格认定进一步凸显了 LBL-024 在解决该治疗领域临床治疗空白方面的巨大潜力。迄今为止我们的临床数据非常令人鼓舞，表明 LBL-024 ...