美国FDA的快速通道(Fast Track)是为了促进治疗严重疾病和解决未满足医疗需求的药物的审评而设立的一种特殊认定。快速通道为药物研发提供了相当大的灵活性,允许FDA根据更多的疗效指标来审批药物。快速通道计划不仅向患者、医生和保险公司传递积极信号,也向投资者发出积极信号。研究表明,获得快速通道称号的适应症在提供QALYs...
The FDA has granted a fast track designation to PT886, a first-in-class native IgG-like bispecific antibody, for metastatic CLDN18.2-positive pancreatic adenocarcinoma treatment.1 PT886 works to target CLDN18.2 and CD47 and was created using proprietary bispecific antibody platforms from Phanes The...
2020年7月17日,索元生物宣布美国食品药品监督管理局(FDA)授予其全球首创新药DB102(Enzastaurin)用于一线治疗脑胶质母细胞瘤(GBM)的快速审评通道(Fast Track)资格认定。能够进入快速审评通道的条件是:目前无有效药物,新药能填补治疗空白,或者新药在有效性或安全性上有明显优势。通过加快药物审评的过程而使这些药物更早...
BNT324/DB-1311 gained fast track designation from the FDA in unresectable advanced or metastatic castration-resistant prostate cancer who have progressed after standard treatments. The FDA has granted a fast track designation to BNT324/DB-1311, an antibody-drug conjugate (ADC), for the treatment ...
The FDA has granted fast track designation to MYTX-011 for use as a potential therapeutic option in patients with non–small cell lung cancer and cMET overexpression. The FDA has granted fast track designation to MYTX-011 for use as a potential...
“The FDA’s decision to grant Tonmya Fast Track designation supports our goal of bringing this well tolerated, non-opioid analgesic treatment option to the market in 2025,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. ...
Tamibarotene plus azacitidine and venetoclax has received FDA fast track designation for newly diagnosed, unfit, RARA-overexpressed AML.
2022年8月23日,泰诺麦博生物(Trinomab)宣布,其自主研发的TNM002注射液获美国食品药品监督管理局(FDA)快速通道(Fast Track)资格。TNM002注射液活性成分为重组抗破伤风毒素全人源单克隆抗体,将用于破伤风的预防。今年3月,TNM002注射液已被中国CDE纳入突破性治疗药物程序。
盟科医药两款产品获QIDP和Fast Track认定 亿欧大健康9月21日讯，生物制药公司盟科医药宣布美国食品药品监督管理局（FDA）授予其自主研发的Contezolid（MRX-I）和其前药Contezolid Acefosamil（MRX-4）用于治疗急性细菌皮肤和皮肤软组织感染（ABBSSI）的合格感染疾病产品（QIDP）和快速通道（Fast Track）认定。QIDP是...
Fast track designation has been granted by the FDA to Deltacel with low-dose radiation for pretreated metastatic non–small cell lung cancer.