"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 ...

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

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

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

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

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

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

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

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

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

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

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