Coming Up On US FDA’s User Fee Calendar: Zynteglo Approval Kicks Off Busy Season For Advanced Biologics, Pediatrics

At least 17 applications are pending with late August and September 2022 user fee goal dates, the Pink Sheet US FDA Performance Tracker shows.

Stem cells — Is the FDA's approval of a new stem cell treatment a harbinger of more approvals in the coming weeks? • Source: Shutterstock

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...