近日,江苏恒瑞医药股份有限公司(以下简称“公司”)收到美国食品药品监督管理局(以下简称“FDA”)的认证函,公司项目注射用SHR-A1921获得美国FDA授予快速通道资格(fast track designation,FTD),这是公司第3款产品获得美国FDA快速通道资格认定。现将相关情况公告如下: 一、药物的基本情况 药物名称:注射用SHR-A1921 剂型:...
KALA Receives FDA Fast Track Designation for KPI-012, a Human MSC-S Therapy for Persistent Corneal Epithelial Defect 眼科 #药闻简讯#2023年4月12日,致力于研究、开发和商业化治疗罕见和严重眼疾的创新疗法的临床阶段生物制药公司$Kala制药(KALA)$美国食品和药物管理局(FDA)已授予Kala的人类间充质干细胞组(...
Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that FDA has granted Fast Track Designation (FTD) to 9MW3011 (R&D code in the US: MWTX-003/DISC-3405) for the treatment of patients with polycythemia vera (PV). Fast Track is a process to f...
Food and Drug Administration (FDA) has granted Fast Track designation and Orphan Drug designation to LX2020, the company’s AAVrh10-based gene therapy candidate designed to intravenously deliver a functional PKP2 gene to cardiac muscle for the treatment of arrhythmogenic cardiomyopathy (...
2024年4月9日,先声药业旗下抗肿瘤创新药公司先声再明宣布,其自主研发的人源化GPRC5D-BCMA-CD3三特异性抗体SIM0500获得美国食品药品管理局(FDA) 授予的快速通道资格,有望加速该药物多发性骨髓瘤适应症的开发。 快速通道资格(Fast Tra...
Omnix Medical announced that the Company has received fast-track designation for its novel anti-infective OMN6 from the U.S. Food and Drug Administration.
FDA授予伏美替尼快速通道(Fast Track Designation ) 在东方财富看资讯行情,选东方财富证券一站式开户交易>> 援引美国药食监局(FDA)与Arrivent消息,7月初第一位晚期或非小细胞肺癌患者已经进入1B期实验。并且,FDA已授予伏美替尼快速通道资格。 这里有两个可以关注的点:...
2024年4月9日,先声药业旗下抗肿瘤创新药公司先声再明宣布,其自主研发的人源化GPRC5D-BCMA-CD3三特异性抗体SIM0500获得美国食品药品管理局(FDA) 授予的快速通道资格,有望加速该药物多发性骨髓瘤适应症的开发。 快速通道资格(Fast Track Designation, FTD)是FDA旨在加速重大疾病药物开发的一种机制,针对严重或危及生命...
近日,恒瑞医药自主研发的TROP-2抗体偶联药物(antibody-drug-conjugate, ADC)注射用SHR-A1921获得美国食品和药物监督管理局(FDA)授予快速通道资格(fast track designation,FTD),用于治疗铂耐药复发上皮性卵巢癌、输卵管癌及原发性腹膜癌(...
CRISPR Therapeutics and Vertex Announce FDA Fast Track Designation for CTX001 for the Treatment of Sickle Cell Disease January 4, 2019 ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, Jan. 04, 2019 -- CRISPR Therapeutics (NASDAQ:CRSP) and Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today ...