FDA Commissioner Marty Makary announced Thursday that the agency will soon provide clear guidelines to vaccine manufacturers ...

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

"Expert Panels with the FDA" are a series of roundtable discussions to provide an open public discourse on the latest medical and scientific information on several important topics. At this roundtable ...

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

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

In an interview on Friday, FDA Commissioner Marty Makary threw his weight behind psychedelic therapies, noting that patients ...

The restrictions on Novavax's vaccine could portend changes at the FDA. Commissioner Marty Makary suggested last week that ...

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 FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for certain ...

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

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

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