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

Seven weeks into his job as FDA commissioner, Marty Makary, MD, MPH, held his own answering a barrage of sometimes ...

The hearing was supposed to focus on the Trump administration’s 2026 budget request, but instead covered a wide range of ...

Government advisers are meeting Thursday to decide if COVID-19 vaccines need updating to improve protection this fall and ...

The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory ...

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 ...

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

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

Seattle vaccine experts were confused by the country's apparent new direction around updated COVID-19 shots, which top FDA ...

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