But the framework has perhaps created as much confusion as clarity. Broadly, the FDA said it will limit approval of Covid-19 ...

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

U.S. health officials knew about the risks of myocarditis from COVID-19 vaccines but downplayed the concern and delayed informing the public about the risks of taking the jab—that is according to a ...

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

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

FDA leaders say the agency will require more clinical trials to show the benefits of annual COVID shots for healthy adults.

Previously, updated COVID vaccines had been recommended annually by the CDC for everyone over the age of 6 months. The CDC has historically set vaccine recommendations, while the FDA determines which ...

The decision means many Americans without underlying conditions may not have access to updated shots this fall."I think we ...

Top health officials were aware of and actively took steps to “delay warning the public” for months in 2021 about the potential risks of patients suffering from heart-related ...

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

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