Lifileucel is indicated for unresectable or metastaticmelanomain adults previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. It is the first autologous T-cell therapy approved for a solid tumor cancer. Accelerated...
Fanapt (iloperidone)– New indication approved for acute treatment of manic or mixed episodes associated with bipolar 1 disorder Onyda XR (clonidine)– New extended-release oral suspension for patients aged 6-17 years with attention deficit hyperactivity disorder (ADHD) Rheumatology Benlysta (belimumab...
FDA批准Tepotinib用于NSCLC 2024年2月,FDA批准Tepotinib(Tepmetko)用于具有间充质上皮转化(MET)外显子14跳跃突变的NSCLC患者。该批准基于VISION试验(NCT02864992)的结果。 原文链接: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-...
FDA. June 12, 2024. Accessed June 12, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-ret-fusion-positive-thyroid-cancer FDA approves durvalumab with chemotherapy for mismatch repair deficient primary advanced or recurrent endometrial...
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. ...
https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications 撰写:Aurora 审校:Bable 排版:Aurora 执行:Faline 医脉通是专业的在线医生平台,“感知世界医学脉搏,助力中国临床决策”是平台的使命。医脉通旗下拥有「临床指南」「用药参考」「医学文献王...
[1] FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer. Retrieved January 17, 2025 from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-...
美国🇺🇸新药批准。 In the last 3 quarters 2024, the FDA has approved 33 novel drugs. The therapeutic areas for novel drugs include: ⚆ Oncology (6) ⚆ Dermatology (5) ⚆ Hematology (4) ⚆ Gastroenterology (3) ⚆ Neurology (3) ...
FDA(fda.gov/)监管的项目除了包含药品(化药、生物制品)、器械(一般设备、辐射器械),还包括食品烟草等。药物临研通常关注药品部分,主要是Drug版块和Vaccines, Blood & Biologics版块。本期通过图解的方法,简单明了地介绍FDA这两个版块搜索美国已获批药品的说明书、综述资料的方法。 Drugs 常规药物 信息搜索疫苗、细胞...
Weight loss drugs approved by the FDA since 2012 include:Zepbound (tirzepatide) Wegovy (semaglutide) Saxenda (liraglutide) Contrave (bupropion and naltrexone) Qsymia (phentermine and topiramate)The generic liraglutide option for Victoza was approved by the FDA on December 23, 2024. The generic is...