The decision applies to adolescents and adults and aligns with earlier US authorization for higher-risk groups.

Moderna recently faced pressure after the U.S. Food and Drug Administration announced plans to require more rigorous safety ...

Vinay Prasad, a top FDA official, blamed COVID shots for playing a role in the deaths of 10 children in a memo he sent to ...

Shares of two major Covid-19 vaccine makers declined Monday after a Food and Drug Administration official [claimed the shots]( ...

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans.

GSK said on Friday a panel ‍of the European Medicines Agency had backed the use of its ‌respiratory syncytial ‌virus (RSV) ...

The top vaccine chief at the Food and Drug Administration sent out a memo saying the FDA will seek a stricter review and ...

The FDA’s top vaccine regulator outlines proposed changes to the vaccine evaluation process in an internal memo.

Shares of several major vaccine makers lost ground Monday following a report U.S. vaccine approval rules could become ...

"He is swayed by data, the scientific method, and clinical experience" but a mob got Kirk Milhoan fired because he leads a ...

The FDA is reportedly considering the addition of high-level warning labels to COVID vaccines, a move that some experts say ...