In a major policy shift, federal health officials anticipate the shots will be made available to adults 65 and older as well ...

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

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

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 ...

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

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

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans. The agency is changing ...

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

FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...