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 ...

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

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

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

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

Lisa Jarvis The controversial appointment of oncologist Vinay Prasad — an outspoken critic of the pharmaceutical industry and U.S. health agencies — to a key role within the Food and Drug ...

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 — ...

The U.S. Food and Drug Administration has given marketing clearance to a blood test to help diagnose Alzheimer’s disease, making the test the first to get signoff to aid in the early detection of the ...