2022年回顾：美国食品药品监督管理局（FDA）批准的新药
2022 in review: FDA approvals of new medicines.
作者信息
Kinch Michael S, Kraft Zachary, Schwartz Tyler
机构信息
Center for Research Innovation in Biotechnology, Long Island University, 720 Northern Blvd, Greenvale, NY 11548, USA.
Center for Research Innovation in Biotechnology, Long Island University, 720 Northern Blvd, Greenvale, NY 11548, USA.
出版信息
Drug Discov Today. 2023 Aug;28(8):103622. doi: 10.1016/j.drudis.2023.103622. Epub 2023 May 16.
An accounting of all new entities approved by both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) identified the approval of 44 new entities in the year 2022. Oncology-based drugs continued to be the most popular indication for these medicines. Likewise, orphan indications encompassed more than half of new drug approvals. The number of new entities approved in 2022 declined from its peak after 5 years of more than 50 annual approvals. Likewise, the rate of consolidations slowed somewhat, among both new entries in the realm of clinical-stage developers and more established organizations.
药品评价和研究中心（CDER）与生物制品评价和研究中心（CBER）批准的所有新实体的统计显示，2022年有44个新实体获批。基于肿瘤学的药物仍然是这些药物最常见的适应症。同样，罕见病适应症占新药获批数量的一半以上。2022年获批的新实体数量从连续5年每年超过50个获批的峰值有所下降。同样，在临床阶段开发者领域的新进入者和更成熟的组织中，合并率也有所放缓。
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