FDA commissioner Dr. Marty Makary shared a major outcome: “Today, we met our goal ahead of schedule and under budget,” he said. “What took one scientific reviewer two to three days [before] ...

Two common allergy medications could cause a severe reaction in some people who stop using it. The U.S. Food and Drug Administration (FDA) issued an alert related to cetirizine (Zyrtec) or ...

But this year's meeting was awkward and even a little tense. Earlier this week, new FDA leaders under health secretary and anti-vaccine advocate Robert F. Kennedy Jr. announced a sweeping new ...

"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 ...

The Food and Drug Administration’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory processes. The first sign of trouble was the ...

The majority of Americans may be ineligible for a COVID booster shot this year, according to new guidelines from the Food and Drug Administration (FDA). In an article published Tuesday in The New ...

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 ...

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 ...

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 ...

“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 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 ...

Top FDA official shares the agency’s playbook for pushing manufacturers to remove synthetic dyes and reduce sugar and sodium – stressing the importance of collaboration with ‘co-regulators ...