But with FDA action, it would be the third vaccine against Covid-19 to receive full FDA approval. Full approval would make the vaccine available beyond an emergency declaration and could provide ...

Concern is growing among public health experts that anti-vaccine sentiments within federal and state governments may derail ...

In the wake of unprecedented workforce cuts at the FDA, former Commissioner Scott Gottlieb and an unnamed former CBER ...

The FDA has allowed emergency use of Novavax’s Covid-19 vaccine. It set an April 1 deadline for a decision on whether to grant a normal, full approval, the people said. The decision would have cleared ...

As the Trump administration cuts thousands of federal jobs, some fired workers worry about health agencies' ability to ...

Novavax started the week hoping the FDA would issue a full approval of its Covid vaccine. But the decision never came.

Marking the first approval in over a decade for this challenging condition, the FDA has approved dupilumab (Dupixent) to treat chronic spontaneous urticaria in patients 12 years and older whose hives ...

The delayed decision comes amid a major organizational shakeup that included the departure of top vaccine official Peter ...

declared that U.S. Food and Drug Administration approval for COVID-19 vaccines should be yanked, asserting that the jabs "are causing permanent harm and deaths." "FDA approval for COVID-19 ...

Peter Marks, the Food and Drug Administration (FDA) official pressured to resign over his disagreements with Health and Human ...

Officials at the Department of Health and Human Services have struggled to find records belonging to Dr. Tom Shimabukuro, the director of the CDC’s Immunization Safety Office.

A person familiar with the situation told CNN that the FDA is seeking more data on the vaccine, which has been available under emergency use authorization since 2022. It was the first Covid-19 ...