Keeping Track: Axsome’s Auvelity Survives Long Review; Bluebird’s Zynteglo Cleared For Liftoff; Omeros Appeals CRL

The US Food and Drug Administration approval of bluebird bio’s gene therapy Zynteglo on 17 August ended an almost two-month drought in novel agent approvals, but the action also brought into focus just how much slower novel approvals have been coming this year compared to 2021.

Zynteglo is the fourth novel biologic to clear the FDA Center for Biologics Evaluation and Research in 2022, putting CBER only 36% of the way to matching