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

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

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

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

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

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

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 ...

Help Register Login Login Hi, %{firstName}% Hi, %{firstName}% Games Car rental The U.S. Food and Drug Administration (FDA) ...

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

Top officials in the Trump administration on Tuesday announced they will limit the approval of new COVID-19 vaccines to ...