The FDA "has failed in its responsibility to protect patients and families from unproven treatments with known harms" in approving Biogen's Alzheimer's disease drug Aduhelm.
Biogen and Eisai have defied the naysayers and secured an historic FDA approval for their amyloid-targeting antibody aducanumab as the first-ever disease-modifying treatment for Alzheimer's
The FDA got too close to Biogen during the development of the Alzheimer’s drug aducanumab, according to its own expert advisers who are urging the regulator to reject it in the coming weeks
The FDA has delayed its decision on aducanumab, the troubled Alzheimer's drug from Biogen and Eisai by three months, raising hopes that it could be approved after all.
When Eli Lilly reported results for donanemab in Alzheimer’s disease earlier this week it was hailed as a rare win for the amyloid hypothesis, although there’s no shortage of candidates tha
The FDA may have been minded to approve Biogen and Eisai’s Alzheimer’s candidate aducanumab, but its clinical advisors have little doubt that the evidence for the drug is lacking.<