Aducanumab Approval Decision Delayed: What’s In The Major Amendment?
From EMBARK data to labeling materials, the potential reasons for the three-month user fee delay are as varied as the ups and downs of the Biogen/Eisai Alzheimer’s candidate’s development saga.
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Dunn’s participation at the panel meeting ended speculation that he left the US FDA.
Public Citizen proposal that FDA staff who provide presubmission advice on a development program not be involved in reviewing the subsequent product application would cause significant public health repercussions and delay drug development, acting commissioner says; Public Citizen had cited ‘close collaboration’ between the FDA and Biogen on aducanumab in calling for the separation.
Wall Street Sees Woodcock Commissionership As Positive for Aducanumab, But Eyes Should Be On Cavazzoni
Review extension for Alzheimer’s candidate may be positive for Biogen, but it’s not because Woodcock is acting commissioner. To understand the odds, it may be time to get to better know a new generation of US FDA’s drug review leadership.