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

Young athletes are lifting weights and taking over-the-counter dietary supplements in an attempt to gain size and power. How ...

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 ...

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

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 vaccine will only be available to those at high risk from Covid—excluding those who may need it to protect a relative or ...

In a conversation with The Regulatory Review, public health expert Mitch Zeller reflects on his tenure at the U.S. Food and ...

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 ...

In recent years, Kessler has lost considerable weight himself with the help of the new GLP-1 drugs. He describes his weight ...