The FDA is requiring COVID vaccine makers Pfizer and Moderna to update their warnings about the possible risk of myocarditis ...

In a major policy change, the Food and Drug Administration has announced a plan to limit access to future COVID-19 shots only ...

Regulators say updated booster shots won’t be approved for healthy people under age 65 unless drugmakers conduct new trials.

In this week’s edition of InnovationRx, we look at the FDA's new rules on Covid-19 vaccines, Novartis’s acquisition strategy, ...

A day after the FDA tightened the restrictions for winning vaccine approvals, Moderna Inc. is pulling its application for ...

FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad set stricter approval standards for booster shots ...

The FDA will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to ...

The U.S. Food and Drug Administration on Tuesday said it plans to require new clinical trials for approval of annual COVID-19 ...

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit ...

Seattle vaccine experts were confused by the country's apparent new direction around updated COVID-19 shots, which top FDA ...

The FDA will make it more costly to seek approval of Covid-19 vaccines, but Moderna's shareholder reacted favorable to the ...

Health experts say there are legitimate questions about how much everyone still benefits from yearly COVID vaccination or ...