FDA药品审批趋势：2021-2024洞察与创新。

IF 1.1 Q4 PHARMACOLOGY & PHARMACY

Annales pharmaceutiques francaises Pub Date : 2025-06-27 DOI:10.1016/j.pharma.2025.06.004

Geet Raut, Sanjay Sharma

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引用次数: 0

摘要

从2021年到2024年，美国食品和药物管理局（FDA）批准了新药，推进了神经病学、肿瘤学、传染病和罕见疾病的治疗。本综述分析了批准趋势，突出了靶向疾病和生物制剂，加速途径的兴起，重点关注未满足的医疗需求，并审查了不同类别的关键治疗领域的批准趋势。该分析利用了FDA药物评估和研究中心（CDER）的数据，为新药适应症、监管创新及其对医疗保健的影响提供了见解。该评论分析了药物批准的趋势。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Trends in FDA drug approvals: 2021-2024 insights & innovations.

From 2021-2024, the U.S. Food and Drug Administration (FDA) approved novel drugs, advancing treatments in neurology, oncology, infectious diseases and rare disorders. This review analyzes approval trends, highlighting the targeted diseases and biologics, the rise of expedited pathways and focus on unmet medical needs. These examines key therapeutic areas the approval trends of different categories. The analysis draws on data from the FDA's Center for Drug Evaluation and Research (CDER) to provide insights into novel drug indication, regulatory innovations and their implications to healthcare. The review analyzes trends in drug approvals.

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来源期刊

Annales pharmaceutiques francaises PHARMACOLOGY & PHARMACY-

CiteScore

1.70

自引率

7.70%

发文量

期刊介绍： This journal proposes a scientific information validated and indexed to be informed about the last research works in all the domains interesting the pharmacy. The original works, general reviews, the focusing, the brief notes, subjected by the best academics and the professionals, propose a synthetic approach of the last progress accomplished in the concerned sectors. The thematic Sessions and the – life of the Academy – resume the communications which, presented in front of the national Academy of pharmacy, are in the heart of the current events.