必应词典为您提供Fast-Track-Designation的释义,网络释义: 快速审定资格;快速审核资格;快速跟踪计划;
“The FDA Fast Track Designation for our dual agonist is an important step forward in addressing the high unmet medical need among the up to 444 million adults estimated to be living with NASH,” said Waheed Jamal, MD, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer In...
Fast track designation for Fabry disease therapy
“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. ...
The FDA has granted a fast track designation to SYNC-T SV-102, an investigational therapy for patients with metastatic castrate-resistant prostate cancer (mCRPC), according to a news release from Syncromune, the developer of the agent.1
Fast track designation has been granted by the FDA to Deltacel with low-dose radiation for pretreated metastatic non–small cell lung cancer.
FDA授予伏美替尼快速通道(Fast Track Designation ) 炒股第一步,先开个股票账户 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...
The Fast Track designation provides several benefits, including more frequent meetings with the FDA to discuss the drug's development plan, eligibility for Accelerated Approval and Priority Review if relevant criteria are met, and a potential Rolling Review of the New Drug Application...
The Fast Track designation provides several benefits, including more frequent meetings with the FDA to discuss the drug's development plan, eligibility for Accelerated Approval and Priority Review if relevant criteria are met, and a potential Rolling Review of the New Drug Application (NDA). ...
Tamibarotene plus azacitidine and venetoclax has received FDA fast track designation for newly diagnosed, unfit, RARA-overexpressed AML.