Revisiting FDA approval of aducanumab

New England Journal of Medicine

28 July 2021 - Given the scientific, regulatory, and clinical implications of the accelerated FDA approval of aducanumab for Alzheimer’s disease, it’s essential to consider beta-amyloid’s suitability as a surrogate end-point. 

Doing so casts doubt on the wisdom of the decision.

Read New England Journal of Medicine Perspective

Michael Wonder

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Michael Wonder

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Medicine , US , Regulation