FDA to decide on full approval of Alzheimer's treatment Leqembi in early July
The FDA will decide on July 6 whether to grant full approval to the new Alzheimer's treatment Leqembi, Japanese drugmaker Eisai and its U.S. partner Biogen said.
FDA rejects Lilly’s alzheimer’s drug candidate, seeks more data
Lilly said it would work with the FDA to evaluate the fastest pathway to get its Alzheimer’s drug to market after what it believes was a successful trial.
House committee questions Biogen drug approval process
The FDA's approval process of Biogen's Alzheimer's drug was questioned in a Congressional report released Thursday.
Americans are using Apple AirTags to track loved ones with dementia, report says
Some people are turning to Apple's AirTags to track loved ones with dementia. Public health officials warn it may not be the best choice, not just due to its tracking ability.
FDA approves Amylyx ALS drug
Amylyx says doctors will be able to prescribe Relyvrio immediately. The drugmaker anticipates prescriptions will be filled and shipped from specialty pharmacies within the next four to six weeks.
Biogen shares soar on Alzheimer's drug developments
A study found that Biogen's Alzheimer's drug lecanemab reduced cognitive and functional decline by 27% compared to a placebo over an 18-month period.
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.
Sonic weapon used to attack U.S. diplomats in Cuba?
Sonic weapons explained
Pharmacy boss blamed for meningitis outbreak gets 9 years
The co-founder of a Massachusetts compounding pharmacy is set to be sentenced in a deadly nationwide meningitis outbreak that killed more than 60 people and sickened hundreds more.