近日，美国FDA药物评价与研究中心（CDER）发布了该机构2025年新药审评年度报告。报告指出，FDA在新药审评与批准方面持续保持高效与稳定的节奏，围绕疾病的预防、诊断、治疗与治愈，推动了一批具有重要临床意义的创新疗法进入临床应用。这些获批药物覆盖多 ...

近日，美国食品药品监督管理局 （FDA）药品评价与研究中心（CDER）发布 2025 年新药审评年度报告。报告显示，2025 年 CDER 共计批准 46 款新药，结合 2016 至 2025 年十年数据来看，CDER 年均批准新药约 47 款，2025 年的获批数量与这一长期平均水平基本持平。

*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 CDER药品质量办公室（OPQ）药品质量审评第1办公室（OPQA I）主任Geoffrey ...

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 ...

Add Yahoo as a preferred source to see more of our stories on Google. The US Food and Drug Administration (FDA) has a new chief drug regulator, with industry veteran Dr Richard Pazdur taking the helm ...

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 ...

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 ...

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 ...

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 ...