Newly disclosed FDA documents reveal agency’s unprecedented path to approving Aduhelm
Chastened after a decisively negative review from outside advisers, the Food and Drug Administration convened a series of internal meetings in March and April where top officials hammered out a plan to approve Biogen’s Alzheimer’s drug, Aduhelm.
The meetings were revealed in a series of documents released Tuesday by the FDA to explain its decision to use a truncated pathway, called accelerated approval, to approve Aduhelm.
