In a significant shift of federal vaccine policy, the Food and Drug Administration announced Tuesday that access to updated ...

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

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 ...

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

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

President Donald Trump’s administration is slated to lay out its approach to Covid vaccination at an event Tuesday that could ...

The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, ...

The US Food and Drug Administration changes Covid-19 vaccine approval process. Access to seasonal boosters is restricted for ...

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 agency will require manufacturers to conduct randomized, controlled trials to secure approval for healthy Americans.