The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.

The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new ...

The FDA said moving forward, it will adopt a framework requiring proof that a vaccine can generate antibodies in people over ...

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

The agency is changing the standard of evidence required for Covid-19 vaccine approval in the US, Dr. Vinay Prasad, the new ...

The FDA announced it will limit access to Covid-19 vaccines going forward to people 65 and older and others at high risk of ...

"The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at ...

Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.

In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the ...

Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many ...

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

With new testing requirements, it’s not even clear whether new Covid or flu shots can be made available this fall.