它靶向 SERPINC1 基因的 mRNA，通过抑制肝脏中抗凝血酶的产生，促使凝血酶生成增加，从而恢复血友病患者的凝血功能，重新平衡止血功能。在中国，CDE 已在 2024 年 5 月受理了 Fitusiran 注射液的新药上市申请。七款分子链接直达往期推荐JAK 抑制剂联合疗法三期临床结果出炉，疗效 & 安全性俱佳！新发现！铜螯合剂 T...
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...
CLDN18.2-positive locally advanced unresectable or metastaticgastric or gastroesophageal junction (GEJ) adenocarcinoma. The VENTANA CLDN18 (43-14A) RxDx Assay is approved as a companion diagnostic
Farxiga (dapagliflozin)andXigduo XR (dapagliflozin/metformin)– Indication for type 2 diabetes mellitus expanded to include children aged 10 years and older Cite this: Mary L. Windle. FDA Drug Approvals Q2 2024 -
盘点:2024前三季度FDA批准的34款新药参考资料: 1. Novel Drug Approvals for 2025 from https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 2. https://go.drugbank.com 3.https://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate...
参考文献: Huseyin Naci, et al., Overall survival benefits of cancer drugs initially approved by the US Food and Drug Administration on the basis of immature survival data: a retrospective analysis, Lancet Oncol. 2024. ...
CDER approved 50 novel drugs in 2024, record number of biosimilars 2025年1月9日，FDA CDER发布了一份年度报告，总结了2024年批准的药物和生物类似药情况。报告显示，CDER在2024年共批准了50种新药、创纪录数量的生物类似药以及显著数量的罕用药指定疗法。 2024年获批的新药涵盖了感染性疾病、神经系统疾病、阿片...
1.https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 2.https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2023-biological-license-application-approvals 3.https://www.fda.gov/media/...
0.0001)。资料来源：FDA官网 https://endpts.com/every-fda-drug-approval-from-2023-full-list-of-approved-new-drugs/ 声明：本文系药智网转载内容，图片、文字版权归原作者所有，转载目的在于传递更多信息，并不代表药智网立场。如涉及作品内容、版权和其它问题，请在本平台留言，我们将在第一时间删除。
1.https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 2.https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2023-biological-license-application-a...