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...
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...
FDA Commissioner Says Willing to Fast-Track COVID-19 Vaccine: FT More Reuters FILE PHOTO: Commissioner of U.S. Food and Drug Administration Dr. Stephen M. Hahn speaks during a news conference about the latest coronavirus disease (COVID-19) developments, in the Brady Press Br...
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: 一是有了FDA的快速通道后,能够加快伏美替尼的开发与审查,使得Arrivent与FDA更频繁、更顺畅的沟通,客观上有利于伏美替尼的加快批准,对于伏美替尼用于...
/PRNewswire/ -- Aspen Neuroscience today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for ANPD001 for the...
FDA offers fast-track approval for lower-cost AIDS combinations
, Sept. 26, 2024 /PRNewswire/ -- PTC Therapeutics (NASDAQ: PTCT) announced today that the FDA has granted Fast Track designation to the PTC518 program for the treatment of Huntington's disease. Fast Track designation is awarded to promising therapies for diseases of high unmet need....
Fast Track designation by the FDA is intended to facilitate development and expedite review of therapies to treat serious and life-threatening conditions with no or limited treatment options so that an approved product can reach the market expeditiously. Under Fast Track designation, a Biologic License...
The FDA has granted a fast track designation to padeliporfin Immune Photo Activated Cancer Therapy (ImPACT) for use in the treatment of patients with low-grade and unifocal upper-tract urothelial cancer (UTUC), according to an announcement from Steba Biotech.1The decis...
The FDA has granted fast-track designation to a proprietary, scalable, allogeneic, investigational cellular therapy in development to address symptoms of mild Alzheimer’s disease, according to the manufacturer. Lomecel-B (Longeveron Inc.) was investigated in a just-completed phase 2a cli...