In its Friday approval letter, the FDA didn’t explain the restrictions although they reflect skepticism about ...

The U.S. Food and Drug Administration on Friday approved Novavax's COVID-19 vaccine, but placed additional conditions on ...

After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter ...

Japan-based Fujirebio's test, which helps doctors diagnose Alzheimer's disease, is intended for patients with signs of ...

The test measures two proteins that are linked to amyloid plaques in the brain, which are among the hallmarks of Alzheimer's.

The US Food and Drug Administration has given marketing clearance to a blood test to help diagnose Alzheimer’s disease, ...

The new test, known as the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, detects amyloid plaques through blood testing, a ...

The new test, from Fujirebio Diagnostics, Inc., identifies a sticky brain plaque, known as beta-amyloid, that is a key marker ...

Bayer Pharmaceuticals' chief operating officer said the head of the top U.S. drug regulator recently reassured industry ...

The Food and Drug Administration cleared a new kind of test for Alzheimer’s disease designed to be more accessible and less ...

The FDA has cleared the first-ever blood test for early Alzheimer's detection, which the agency says reduces the need for ...