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

U.S. Food and Drug Administration advisers unanimously recommended on Thursday that COVID-19 vaccines for the 2025-26 period ...

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.

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

A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make ...

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

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 ...

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

The announcement, which followed the FDA setting new guidelines on COVID vaccine approvals, erased the stock’s gains from ...

FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...