Liang Chang, Min Wang, Huijie Zhang, Zhen Li, Zixuan Song, Lijie Zhao, Fengli Jiang, Jiao Wang, Yuan Quan
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引用次数: 0
Abstract
In 2025, the U.S. Food and Drug Administration (FDA) continued to advance therapeutic innovation by approving a diverse range of novel drugs. According to the FDA's 2025 Novel Drug Approvals list, 46 new drugs received approval, including both new chemical entities such as Ziftomenib, Sevabertinib, Zoliflodacin, and Gepotidacin, as well as new biologics. These approvals cover a wide range of therapeutic areas, including oncology, rare genetic diseases, infectious diseases, cardiovascular diseases, and immunomodulation. A significant proportion of the approved products navigated accelerated or priority review pathways, reflecting their potential impact on unmet medical needs. This review provides a comprehensive overview of the synthetic routes and clinical applications of FDA-approved small-molecule drugs in 2025, aiming to inspire future development in drug discovery.
期刊介绍：
Medicinal Research Reviews is dedicated to publishing timely and critical reviews, as well as opinion-based articles, covering a broad spectrum of topics related to medicinal research. These contributions are authored by individuals who have made significant advancements in the field.
Encompassing a wide range of subjects, suitable topics include, but are not limited to, the underlying pathophysiology of crucial diseases and disease vectors, therapeutic approaches for diverse medical conditions, properties of molecular targets for therapeutic agents, innovative methodologies facilitating therapy discovery, genomics and proteomics, structure-activity correlations of drug series, development of new imaging and diagnostic tools, drug metabolism, drug delivery, and comprehensive examinations of the chemical, pharmacological, pharmacokinetic, pharmacodynamic, and clinical characteristics of significant drugs.
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