阿舍·穆拉德 | 撰文潘展 | 编译最近，Nature Reviews Drug Discovery盘点2025年美国FDA药物评估与研究中心（CDER）批准了46种新治疗药物。这一数字使得五年平均获批量略微下降，达到每年48种新药。但批准数量仍远高于自1993年以来每年36种新药的历史平均水平。图1 CDER每年批准的NMEs和BLA数量 ...

*题图由AI生成，仅作示意用。近日，ICH在其指南列表页面悄无声息地更新了一个条目，即“M16 EWG 结构化产品质量申报”（暂译，Structured Product Quality submissions，SPQS）。ICH组建了以FDA ...

2025 年，尽管美国食品药品监督管理局（FDA）经历了人事变动和政策调整的动荡一年，其药物评估与研究中心（CDER）仍批准了 46 款新治疗药物。这一数字虽使五年平均获批数微降至每年 48 款，但仍远高于 1993 年以来 每年 36 款的历史平均水平。同时，FDA 生物制品评估与研究中心（CBER）也批准了 8 款重要新产品，包括首款来自非营利组织的基因疗法。

WASHINGTON, Aug. 21, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (VNDA) today announced that it has asked Martin Makary, the Commissioner of the U.S. Food and Drug Administration (FDA) to review ...

WASHINGTON, Aug. 21, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has asked Martin Makary, the Commissioner of the U.S. Food and Drug Administration ...

ETFs representing global drug companies reached a record high after the U.S. Food and Drug Administration (FDA) announced the appointment of Richard Pazdur, its top cancer drug regulator, as the head ...

In a surprise move, the FDA has named the longtime leader of its oncology department, Richard Pazdur, M.D., as the new director of the Center for Drug Evaluation and Research, which oversees most ...

The U.S. FDA once again has a leadership gap at the top of its drug center, which already has been ravaged this year by massive terminations, resignations and retirements of senior leaders. George ...

Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics ...

The US Food and Drug Administration (FDA) has selected Tracy Beth Høeg as its new head of drug research and evaluation – marking another leadership change in a tumultuous period for the agency. Høeg’s ...

In reaching within to name 26-year FDA veteran Richard Pazdur as the next CDER director, FDA Commissioner Marty Makary likely chose the best possible person to helm the drug evaluation center at a ...