bluebird bio (BLUE) Confirms FDA Approval of ZYNTEGLO Gene Therapy

bluebird bio (BLUE) Falls to Low, Down 18%

bluebird bio (NASDAQ: BLUE) Falls to Low, Down 18%

UPDATE: bluebird bio's (BLUE) Zynteglo Gets FDA Approval - List Price In-Line Says Analyst

(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

bluebird bio (BLUE) Resumes Trading, Up 20%

bluebird bio (NASDAQ: BLUE) Resumes Trading, Up 20%

bluebird bio (BLUE) to Resume Trading at 2:30 p.m.

bluebird bio (NASDAQ: BLUE) to Resume Trading at 2:30 p.m.

bluebird bio (BLUE) to Charge $2.8M for Fda-Cleared Blood Disorder Therapy - Bloomberg

bluebird bio (NASDAQ: BLUE) to Charge $2.8M for Fda-Cleared Blood Disorder Therapy - Bloomberg

FDA Approves bluebird bio's (BLUE) Cell-Based Gene Therapy to Treat Adult and Pediatric Patients with Beta-thalassemia Who Require Regular Blood Transfusions

Today, the U.S. Food and Drug Administration approved Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions.

"Today's approval is an important advance in the treatment of beta-thalassemia, particularly in individuals who require ongoing red blood cell transfusions," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. "Given the potential health complications associated with this serious disease, this action highlights the FDA's continued commitment to supporting development of innovative therapies for patients who... More

bluebird bio (BLUE) Halted, News Pending

bluebird bio (NASDAQ: BLUE) Halted, News Pending