A recent memo from Dr. Vinay Prasad​, the head of the FDA's Center for Biologics Evaluation and Research, may signal an ...

A strict new vaccine approval process in the U.S. could dramatically slow things down for biopharma and the public, experts ...

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.

The U.S. Food and Drug Administration (FDA) is considering adding the strongest safety warning available to COVID-19 vaccines ...

The Food and Drug Administration (FDA) is investigating whether the COVID-19 vaccines were associated with any deaths across ...

The FDA vaccine approval road map proposes longer trials and stricter evidence to improve vaccine safety and effectiveness oversight.

The U.S. Food and Drug Administration has no plans to put a "black box" warning on COVID-19 vaccines, Bloomberg News reported ...

The former officials said the FDA's plans to revamp how certain life-saving vaccines are handled would "disadvantage the people the FDA exists to protect, including millions of Americans at high risk ...

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

The FDA intends to place a black box label—its most serious warning—on COVID-19 vaccines, according to reporting by CNN. It ...

The US Food and Drug Administration has no plans to put a “black box” warning on Covid vaccines, the agency’s top official ...

The plan, which is not finalized, suggests children get fewer shots and shifts to a model telling parents to consult doctors ...