As Aducanumab’s US FDA Review Progressed, Support Grew For Accelerated Approval

Use of expedited pathway for Biogen's Alzheimer's drug was discussed at a center director briefing in late April, where it garnered backing from several senior CDER officials, as well as CBER director Peter Marks and OCE director Richard Pazdur.

Momentum
The idea of accelerated approval gained momentum late in Aduhelm's regulatory review. • Source: Alamy

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