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 ...

While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner ...

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

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

Health agencies working under Robert F. Kennedy Jr. are making changes to the nation's decades-old system for approving and ...

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

Companies focused on psychedelic medicines traded higher for the second straight session on Tuesday after FDA Commissioner ...

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

Before being confirmed as the head of the U.S. Food and Drug Administration (FDA) on March 25, Dr. Marty Makary was an ...