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bluebird bio announces positive recommendation by EU PRAC committee regarding safety referral review of Zynteglo for transfusion-dependent beta-thalassemia and marketing to resume in EU.bluebird bio announces positive recommendation by EU PRAC committee

Read time: 1 mins
Last updated:28th Jul 2021
Published:10th Jul 2021
bluebird bio, Inc announced that the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded based on the review of all available data that the benefit-risk balance of medicinal products containing Zynteglo (betibeglogene autotemcel gene therapy) remains favorable. As of today, bluebird bio has informed the EMA that the company is lifting the voluntary marketing suspension.
Condition: Beta-thalassemia
Type: drug
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