In November 2020, Biogen, Inc.'s Aduhelm (aducanumab-avwa) exited a US Food and Drug Administration advisory committee review with little to no support from the agency's external experts for regular approval, despite a strong endorsement by the FDA clinical review team and Office of Neuroscience leadership.
However, as the Alzheimer’s drug’s tangled regulatory review progressed, it gained backing for accelerated approval across multiple offices and centers...