FDA approves marketing for new Alzheimer's early detection test
The Lumipulse G β-Amyloid Ratio (1-42/1-40) test is available at clinical laboratories nationwide for adult patients aged 55 years and older who are presenting with cognitive impairment and being evaluated for Alzheimer’s disease and other causes of cognitive decline.
Biogen shares slip as Alzheimer's drug faces new setback
Shares of Biogen slipped nearly 4% in pre-market trading Wednesday after the biotech company's new Alzheimer's drug Aduhelm (aducanumab) received a "negative trend vote" from the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP).
In quiet debut, Alzheimer’s drug finds questions, skepticism
The first new Alzheimer’s treatment in more than 20 years was hailed as a breakthrough when regulators approved it more than four months ago, but its rollout has been slowed by questions about its price and how well it works.
FDA approved Biogen Alzheimer’s drug despite some staff concerns
The U.S. Food and Drug Administration approved the first new Alzheimer’s drug in decades over the objection of agency statisticians who said there was insufficient evidence to support approval, according to newly released internal memos.