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May 5, 2022 News by Steve Bryson, PhD

FDA Grants Fast Track Status to SCD Gene-editing Therapy GPH101

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…

May 30, 2019 News by Ana Pena, PhD

FDA Grants Fast Track Status to Imara’s IMR-687 Candidate Therapy for Sickle Cell Disease

IMR-687, an investigational therapy for sickle cell disease, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). It’s currently being evaluated in a Phase 2a trial in the U.S. and U.K. The Fast Track process is meant to get new therapeutics that treat…

January 7, 2019 News by Patricia Inácio, PhD

CTX001 Earns FDA’s Fast Track Status for Treating Sickle Cell Disease

The U.S. Food and Drug Administration (FDA) has awarded fast track status to investigational therapy CTX001 to treat sickle cell disease. A Phase 1/2 clinical trial (NCT03745287) is recruiting patients. CTX001 uses the CRISPR gene-editing technology to increase the production of fetal hemoglobin in patients’ red blood cells. Fetal hemoglobin is…

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  • Reflecting on 4 years of sharing my experiences with sickle cell
  • Level of physical activity tied to less pain, blood viscosity in SCD: Study
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