The US Food and Drug Administration approval of bluebird bio’s cell-based gene therapy Zynteglo (betibeglogene autotemcel) on 17 August could be seen as a positive omen for the coming month, when agency decisions are due on two more novel advanced biologic products and at least five applications carrying breakthrough therapy designations (BTDs), according to the Pink Sheet FDA Performance Tracker.
Zynteglo is intended as a one-time treatment for adult and pediatric patients with beta-thalassemia who require regular red blood cell...
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