In a somber end to an FDA advisory committee’s two-day scouring of multiple drugmakers’ oncology data, Pfizer’s pitch to ...

The FDA’s independent advisors found Pfizer’s data lacked the precision needed to establish the efficacy of Talzenna in ...

Infectious disease experts say mRNA vaccines have been studied for decades, they are safe and effective, and were instrumental in saving lives during the COVID pandemic.

Advisers to the U.S. Food and Drug Administration on Thursday unanimously voted in favor of recommending that COVID-19 ...

The U.S. Food and Drug Administration approved Novavax's COVID-19 vaccine with age restrictions after a six-week delay.

According to the CDC, cases of myocarditis and pericarditis are rare with the vaccines and, in most cases, resolve within a ...

While the clearance is only for use in certain groups, Novavax’s long-awaited OK is still seen by analysts as a “win” for the ...

This week, mRNA vaccines are set to face intense scrutiny from critics in Congress. Here's an explainer of how we know they ...

A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make a broad recommendation about which lineage of the coronavirus should be ...

One possible explanation for the gap is the availability of highly efficacious CAR-T therapies in the U.S. and Europe serving ...

Healthy younger adults and children will no longer be automatically approved for annual COVID-19 vaccines under a new policy from the FDA.