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

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

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

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 ...

The advisory committee, which met after the agency rolled out new vaccine guidelines, said companies should tailor their ...

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

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

Government vaccine advisers are meeting to decide if the recipe for COVID-19 vaccines needs updating for this fall and winter ...

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

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 ...

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

Novavax's COVID-19 vaccine, Nuvaxovid™, receives limited FDA approval and triggers $175M milestone payment. Commercial ...