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

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

A lot of 2024 retrospectives have been based on vibes. Now we have some really good data. Here’s what it says.

We want to know more about what these products are doing,” said Dr. Vinay Prasad during a recent FDA livestreamed ...

US regulators will no longer approve Covid booster shots for healthy adults and children without new studies, adding a costly ...

Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are ...

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

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

Regulators will require more data showing the shots are safe and effective for healthy adults and children, by requiring ...

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

US regulators will no longer approve Covid booster shots for healthy adults and children without new studies, adding a costly ...

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