FDA lifts hold on studies of bluebird's sickle cell gene therapy in adolescents
In advance of asking for its third gene therapy approval, bluebird bio said the FDA has lifted a clinical hold on its sickle cell disease candidate being investigated in people under the age of 18.
The lift comes almost a year to the day after the Boston-area biotech disclosed the regulator’s hesitancy following a case of persistent anemia in an adolescent, who was not dependent on transfusions.
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