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

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

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

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

Top officials for the FDA laid out new requirements limiting access to yearly COVID shots for healthy younger adults and ...

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

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

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.

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