FDA Approves bluebird bio's (BLUE) Cell-Based Gene Therapy to Treat Adult and Pediatric Patients with Beta-thalassemia Who Require Regular Blood Transfusions
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UPDATE: bluebird bio's (BLUE) Zynteglo Gets FDA Approval - List Price In-Line Says Analyst
August 17, 2022 4:22 PM EDT(Updated - August 17, 2022 4:23 PM EDT)
bluebird bio's (NASDAQ: BLUE) cell-based gene therapy, Zynteglo, has been approved for the treatment of adult and pediatric patients with beta-thalassemia by the U.S. Food and Drug Administration, it was announced Wednesday.
Beta-thalassemia is a type of inherited blood disorder that causes a reduction of normal hemoglobin and red blood cells in the blood. Zynteglo is the first cell-based gene therapy to treat the blood disorder.
Zynteglo is a one-time gene therapy product administered as a single dose. Its safety and effectiveness were established in... More
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... Morebluebird bio (BLUE) Confirms FDA Approval of ZYNTEGLO Gene Therapy
August 17, 2022 2:05 PM EDTbluebird bio, Inc. (Nasdaq: BLUE) today announced the U.S. Food and Drug Administration (FDA) has approved ZYNTEGLO® (betibeglogene autotemcel), also known as beti-cel, a one-time gene therapy custom-designed to treat the underlying genetic cause of betathalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions.
The FDA approval of ZYNTEGLO offers people with beta-thalassemia the possibility of freedom from burdensome regular red blood cell transfusions and iron chelation, and unlocks new possibilities in their daily lives, said Andrew Obenshain, chief executive officer, bluebird bio. After more than a... More
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