WebFeb 26, 2024 · Such forward-looking statements include, but are not limited to, those regarding: Translate Bio’s expectations regarding the potential benefits of Fast Track designation by the FDA for MRT5005 ... WebFeb 7, 2024 · “The FDA’s decision to grant Fast Track designation to NGM621 is an important milestone underscoring the high unmet medical need for patients with geographic atrophy as well as the potential of NGM621 to alter the course of this disease for those underserved patients,” stated Erin Henry Ph.D., Head of Ophthalmology at NGM Bio.
REGENXBIO: FDA Grants Fast Track Designation For RGX-202
WebJan 8, 2024 · Potential First-in-Class Therapy for Chronic Spinal Cord Injury. NEW HAVEN, Conn., Jan. 08, 2024 (GLOBE NEWSWIRE) — ReNetX Bio announced today that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track Designation for ReNetX Bio’s clinical therapy (AXER-204) for the potential treatment of Chronic Spinal … WebMay 5, 2024 · Graphite Bio ’s GPH101, an investigational gene-editing therapy that aims to correct the genetic mutation that causes sickle cell disease (SCD) and potentially cure the condition, has been awarded fast track designation by the U.S. Food and Drug Administration (FDA). The fast track process is designed to accelerate the development … matt tittle football
FDA Grants Fast Track Status to SCD Gene-editing Therapy GPH101
WebJan 8, 2024 · "Fast track designation will help facilitate ReNetX Bio’s development of AXER-204, and potentially expedite future regulatory review of AXER-204 for patients with SCI." About Fast Track Designation WebApr 3, 2024 · NEW YORK--(BUSINESS WIRE)--IVERIC bio, Inc. (Nasdaq: ISEE) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Zimura ® (avacincaptad pegol), a ... WebMay 13, 2024 · "Fast Track Designation represents another positive step for the clinical development of LB1148 and is a clear recognition of the serious need that exists for … mat ttl