Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed approval for drugs to fill unmet needs, federal watchdogs said in a report.
The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for subcutaneous (SC) maintenance dosing of lecanemab-irmb for the treatment of Alzheimer disease (AD) in ...
The lifetime risk of dementia after age 55 is about 42% - more than double the risk reported by earlier studies, and one that puts greater urgency on the need to mitigate addressable health problems, ...
In a simulated trial, the Florey Dementia Index achieved mean absolute errors of 1.57 and 0.70 years for predicting mild cognitive impairment and Alzheimer's disease onset, respectively ...