Novavax originally showed its vaccine was safe and effective in a 30,000-person clinical trial. The FDA had been on track to ...

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

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

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 agency narrowed who can get the shot and added new study requirements that could cost the company tens of millions.

The gravity of these decisions calls for a degree of humility on the part of an FDA leader. And that’s the rub with Vinay ...

The FDA said the results of the newly cleared blood test must be assessed in conjunction with other clinical information from ...

The first-ever blood test to detect Alzheimer’s disease has been cleared by the U.S. Food and Drug Administration (FDA). In a ...

The FDA’s Friday announcement follows an announcement made March 10 by HHS that the agency is revisiting the GRAS final rule for potential reform. Three of the new chemicals that the FDA will study — ...