By recent standards, the first quarter of 2024 has been relatively slow in terms of novel drug approvals. Only 10 new drugs were granted authorization in the first three months of the year (Tablel). This compares to 13 in the first quarter of 2023 -a figure that was equalled or best...
Nat Rev Drug Discov. 2024;23(1):9. doi:10.1038/d41573-023-00202-w [5] Kingwell K. γ-secretase inhibitor notches first approval. Nat Rev Drug Discov. 2024;23(1):9. doi:10.1038/d41573-023-00204-8 [6] Mullard A. FDA approves first Friedreich's ataxia drug. Nat Rev Drug Discov....
2.https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2023-biological-lic...
Finally, Evive’s efbemalenograstim alfa, a dimeric recombinant human granulocyte colony stimulating factor (rhG-CSF)-fc fusion protein, is expecting FDA approval decision on March 30, 2022. The company submitted a BLA in March 2021 for the drug for chemotherapy-induced neutropenia, based on th...
首先,FDA收到NDA或BLA申请数量均呈现上升趋势;标准审评中位时间稳定在10个月左右,90%优先审评中位时间为6个月左右;1993财年产业提交的NDA或BLA首轮批准通过率仅为28%,到PDUFA Ⅰ末(1997财年)提升至44%,至巅峰时期标准审评首轮批准通过率为62%,优先审评首轮批准通过率为85%,据《Novel Drug Approvals for ...
1.Drug: Relatlimab + nivolumab (fixed dose combination) Company: Bristol Myers Squibb Indication(s): Unresectable or metastatic melanoma The first FDA decision to be made in March is on Bristol Myers Squibb’s relatlimab plus nivolumab fixed-dose combination (FDC), seeking marketing approval for...
随着许多富有前景的领域和技术的进一步创新,这些趋势可能会继续保持下去,从而为更多的癌症患者带来希望。 参考文献: 1. Trends in the approval of cancer therapies by the FDA in the twenty-first century. Nat Rev Drug Discov. 2023 Jun 21.
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 ,FDA *声明:本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息,并非也不会进行治疗或诊断方案推荐,也不对相关投资构成任何建议。内容如有疏漏,欢迎沟通指出!
If further post-marketing studies fail to verify the predicted clinical outcome, the FDA may withdraw accelerated approval of the new use or drug. One recent example of a drug that received accelerated approval isElevidys(delandistrogene moxeparvovec-rokl), approved in June 2024 for the treatme...
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