US Food and Drug Administration Commissioner Dr. Marty Makary suggested in a new interview that autism is caused by a range ...

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

The agency is sitting on a decision to grant full approval for Novavax’s shot, days after top vaccine regulator pushed out.

The U.S. Food and Drug Administration has missed its deadline for making a decision on traditional approval for Novavax's ...

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 ...

Tracy Beth Høeg, MD, PhD, who was named a special assistant to new FDA Commissioner Marty Makary, MD, MPH, previously opposed some health policies during the COVID-19 pandemic and has questioned the ...

Mass firings at the FDA have decimated divisions tasked with releasing public records generated by the agency's regulatory ...

The delay dovetails with moves by Republican lawmakers in at least seven states to ban or limit mRNA vaccines. Some, according to KFF Health News, are also pressing regulators to revoke federal ...

When Health Secretary Robert F. Kennedy Jr. announced sweeping job cuts at his department last month, he said that safety ...

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