Today, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that ...
One of the major gene therapy developers to watch in 2022 is bluebird bio. The company has two gene therapies which are expecting FDA approval this year. Betibeglogene autotemcel (beti-cel) is a cell-based gene therapy comprising autologous CD34+ hematopoietic stem cells (HSCs) transduced ex ...
这一公告无疑会促进FDA对细胞和基因疗法的审批速度,改善目前FDA每年只批准2-3款基因疗法的现状,利于基因疗法的实际应用。 在利好政策的推动下,细胞和基因疗法(Cell and Gene Therapy, CGT)行业将迎来快速发展阶段。根据ASGCT的统计,截至2022Q3,全球在研CGT管线达到2031个,呈逐季度上升趋势,尤其是2021年后产品上市数...
One of the major gene therapy developers to watch in 2022 is bluebird bio. The company has two gene therapies which are expecting FDA approval this year. Betibeglogene autotemcel (beti-cel) is a cell-based gene therapy comprising autologous CD34+ hematopoietic stem cells (HSCs) transduced ex ...
UPDATED AUGUST 31 // The first T-cell therapy that uses chimeric antigen receptor (CAR) technology has been approved today by the US Food and Drug Administration (FDA), paving the way for the other products using this novel approach that are in development. "We're entering a new frontier ...
有21个获得了可以提高FDA和药物开发公司之间的沟通水平，及允许FDA对药物申请的部分内容进行滚动审批以加快新药和生物制剂的开发和审批速度为目的的快速通道（Fast Track）指定，占60%；13个获得了包括快速通道途径项目的所有特点并在药物开发过程中可以提供强化的FDA指导的突破性疗法（Breakthrough Therapy）指定，占 37...
对于受CBER监管的机构及其产品,FDA的HCT/Ps官方数据库(HCTERS,Human Cell And Tissue Establishment Registration)可查询已授予认证标识(FEI,FDA Establishment Identifier)的机构,且附对应产品列表[6]。截止至2024年4月,有效注册的机构共有2331家,涉及“...
(Breakthrough Therapy)指定,占 37.1%;23个由于被确定药物可以治疗严重的疾病,且如果批准该药物将显著改善治疗、诊断或预防该严重疾病的安全性或有效性,而获得了旨在提交申请的6个月内而不是标准申请的10个月内FDA采取行动的优先审评(Priority Review)指定,占65.7%;8个...
2024年9月25日,杭州瑞普晨创科技与高校合作Cell发表论文首次公布了利用化 学重编程诱导多能干细胞制备的胰岛细胞移植,治疗1型糖尿病的临床研究。瑞普晨创自主研发的RGB-5088胰岛细胞注射液,是基于先进的化学小分子诱导技术,通过将体细胞重编程为多能干细胞,再进一步制备成胰岛细胞,以替代患者体内丧失功能的胰岛细胞,...
[1] FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease. Retrieved December 18, 2024, from https://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-hos...