Commissioner Makary touts dubious evidence on talcum powder at a rushed hearing.

The US Food and Drug Administration is changing how it approves COVID-19 vaccines for Americans. What does that mean for people wanting to get vaccinations in Australia?

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 ...

The FDA also gave full approval to the Novavax COVID vaccine (Nuvaxovid) using this approach, approving it for those ages 65 ...

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

The new framework was well-received by biopharma analysts, who say it “largely formalizes” current COVID-19 vaccination ...

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.