FDA new drug approvals in Q2 2023doi:10.1038/d41573-023-00117-6Lisa UrquhartNature Publishing Group UKNature Reviews Drug Discovery
In recent years, the FDA has made larger efforts to encourage the development of generic medicines. In 2023, the organisation gave approximately $20m to fund science and research projects. It also expanded the responsibilities of the Generic Drug User Fee Act (GDUFA)-funded Center fo...
surpassing 37 in 2022 and second only to 59 in 20181, [https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023]. Of these novel drugs, 47, or 85.5%, were targeted therapies, reflecting a clear...
After 2022 produced just 37 new drug approvals—the fewest by the FDA since 2016—the United States regulatorsigned offon a bumper crop of 55 new drugs in 2023. The list was the second longest in FDA history, coming up just shy of the single-year record of 59 approvals, ...
[2] https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 [3] https://go.drugbank.com/ [4] Mullard A. FDA approves first-in-class AKT inhibitor. Nat Rev Drug Discov. 2024;23(1):9. doi:10.1038/d41573...
对中国药企来说,紧跟新型上市产品,在此基础上,开发Me better/Best-in-class药物,不管技术门槛还是开发周期和研究成本都会大幅降低。 本文对FDA批准的首个新型药物进行总结,以期给相关研究企业提供参考。 参考文献: New Drug Therapy Approvals 2023 ...
2月20日,四川大学华西医院孙秋研究团队在期刊《Signal Transduction and Targeted Therapy》上发表了题为“Targeted drug approvals in 2023: breakthroughs by the FDA and NMPA”的研究论文,本研究梳理了2023年获FDA和NMPA批准的靶向药物。 https://www.n...
2月20日,四川大学华西医院孙秋研究团队在期刊《Signal Transduction and Targeted Therapy》上发表了题为“Targeted drug approvals in 2023: breakthroughs by the FDA and NMPA”的研究论文,本研究梳理了2023年获FDA和NMPA批准的靶向药物。 https://www.nature.com/articles/s41392-024-01770-y ...
2023 FDA approvals. Nat Rev Drug Discov.doi: doi.org/10.1038/d41573- [2] fda.gov/drugs/new-drugs [3] go.drugbank.com/ [4] Mullard A. FDA approves first-in-class AKT inhibitor. Nat Rev Drug Discov. 2024;23(1):9. doi:10.1038/d41573-023-00202-w [5] Kingwell K. γ-secretase...
2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer. 太平洋证券- 2023 年 FDA 批准新药数量接近记录,创新机制成主流 强生、礼来等公司官网、FDA等公开资料。 免费领取药智数据VIP试用:https://vip.yaozh.com/introducemobile?tryout=1&ga_source=zim...