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

Novavax (NVAX) stock in focus as the U.S. FDA approves its COVID-19 vaccine Nuvaxovid for high-risk groups in the U.S. Read ...

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

After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter from the agency, but only for people 65 and older and those 12 and up who ...

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

FDA approves Lumipulse G, the first blood test that can help in the diagnosis of Alzheimer's disease. Read more here.

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

The Lumipulse Alzheimer's blood test is the first of a new generation of tests that may replace brain scans and spinal taps to detect the disease.

The first in vitro diagnostic device that uses blood samples to detect Alzheimer disease has been granted marketing clearance ...

FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...

The “it goes to 11” of marketing copy. This phrase always looks convincing— it's usually written in all caps at the top of ...

The U.S. Food and Drug Administration announced Tuesday that it is going to remove fluoride prescription drug products for children from the market.