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 ...

WASHINGTON — The Food and Drug Administration has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with ...

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

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.

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

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

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

U.S. health officials have endorsed the first blood test that can help diagnose Alzheimer’s. The test would help identify ...

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

The FDA will prioritize reviews of chemicals including butylated hydroxytoluene (BHT); butylated hydroxyanisole (BHA); and ...