Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in ...

In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...

The U.S. government is nixing a whole slew of "obsolete" U.S. food standards that Trump administration officials say also include "unnecessary" ones.

How did we get here? Until now, vaccines for all children under age 12 had been available under emergency use authorization ...

Public Health – Seattle and King County has seen an increase in emergency visits for COVID-19 over the last month, although ...

Moderna's Spikevax vaccine is the first to receive full approval for use in children aged 6 months to 11 years with a high-risk health issue.

The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.

According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...

Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S. that will no longer be administered under an emergency use authorization.

Pfizer's COVID vaccine (Comirnaty) is fully approved for patients ages 12 and up, and authorized for kids ages 6 months ...

Moderna's Spikevax receives FDA approval for use in high-risk children; Pfizer, BioNTech appeal U.K. ruling in COVID-19 ...

The U.S. Food and Drug Administration has granted full approval for Moderna's MRNA.O COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years who are at an increased risk of the disease, ...