Data from clinical trials of three experimental Alzheimer's disease drugs expected to start emerging next year could help shed light on whether U.S. regulators were justified in their controversial approval of a Biogen Inc treatment without clear evidence that it works.
A U.S. hospital on Wednesday gave the first infusion of an expensive, controversial new Alzheimer's drug from Biogen Inc before Medicare had even said what it will pay for - and with some doctors upset by its approval last week. | Video
June 16 A U.S. hospital on Wednesday will give
the first infusion of an expensive, controversial new
Alzheimer's drug from Biogen Inc before Medicare had
even said what it will pay for - and with some doctors upset by
its approval last week.
In approving the first new Alzheimer's drug in nearly 20 years, the U.S. Food and Drug Administration is taking its biggest risk yet with a strategy that allows new therapies onto the market without strong evidence that they work, regulatory and scientific experts say. | Video
Two members of a panel of outside advisors to the U.S. Food and Drug Administration have resigned in protest at the agency's decision to approve Biogen Inc's Aduhelm for treatment of Alzheimer's disease despite the committee’s recommendation against doing so.
(Reuters) -U.S. regulators on Monday approved Biogen Inc's aducanumab as the first treatment to attack a likely cause of Alzheimer's disease despite controversy over whether the clinical evidence proves the drug works, sending its shares soaring. | Video
The U.S. Food and Drug Administration has approved Biogen's aducanumab, the first drug to target an underlying cause of Alzheimer's disease. The drug, to be sold under the brand Aduhelm, is the first new approval of an Alzheimer's drug since 2003 and the only treatment designed to slow progression of the mind-robbing disease.
June 7 The U.S. FDA on Monday is expected to
give its thumbs up or down on Biogen Inc's aducanumab,
a decision that will affect the future of Alzheimer's disease
research and treatment and show the agency's willingness to
approve badly needed medicines based on less than definitive