"The claim that the FDA is suspending routine food safety inspections is false. FDA is actively working to ensure continuity of operations during the reorganization period and remains committed to ...

FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad wrote in the New England Journal of Medicine that the benefit of repeated annual shots for healthy adults was uncertain ...

The head of the U.S. Food and Drug Administration (FDA) is sounding the alarm on a dangerous drug referred to as "gas station heroin," that can lead to serious harm, including death. FDA ...

The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines, a move that comes as the Trump ...

The U.S. Food and Drug Administration (FDA) is investigating a Listeria outbreak in several Ready-to-Eat foods sold in Washington State, the Administration said in a release. 10 people have been ...

“We want to be very transparent, and we want to create a framework for vaccine makers that they can use so they have a predictable FDA where they don’t have to worry,” Makary said at the ...

The FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for certain approvals. FDA Commissioner Marty Makary, M.D., and Center for Biologics ...

Biohaven is giving investors whiplash. Forty-eight hours after saying its filing was on track, the biopharma revealed the FDA has delayed an approval decision on its rare disease candidate ...

LOOKING INTO VAX CRYSTAL BALL — The Covid-19 vaccine framework that FDA Commissioner Marty Makary teased last week is expected to drop today, two people familiar with the plan and granted ...

Not all people should take Fujirebio's new test. The FDA says that it is "intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline" and is ...

Novavax makes the nation’s only traditional protein-based coronavirus vaccine – and until now it had emergency authorization from FDA for use in anyone 12 and older. But late Friday ...