Monday, June 21, 2021
Thursday, June 17, 2021
FDA advisory panelist outlines numerous issues with aducanumab's accelerated approval for Alzheimer's disease
Despite near unanimous objection from its advisory panel, the U.S. Food and Drug Administration (FDA) granted aducanumab approval to treat Alzheimer's disease on June 7, 2021. In a commentary published in Annals of Internal Medicine, a member and former Chair of the advisory panel and an aducanumab site investigator explain why this unprecedented "accelerated approval" is problematic for clinical research and patient care.