The FDA has examined the results of a recent confirmatory trial to verify the clinical benefit of an amyloid beta-directed antibody for the treatment of Alzheimer disease.
Following two 12-week studies, the FDA has approved the first ever medication for treating agitation in patients with dementia due to Alzheimer disease.
The FDA has granted a landmark approval to an intravenous injection for the imaging of tau pathology among patients with cognitive impairment being evaluated for Alzheimer disease.
This FDA Roundup includes an at-a-glance look at the latest FDA drug approvals in June and July, including the first over-the-counter, nonprescription daily oral contraceptive, the first monoclonal...