Tracy Beth Høeg, MD, PhD, who was named a special assistant to new FDA Commissioner Marty Makary, MD, MPH, previously opposed ...

Vaccine maker Novavax's shares plunged over 22% on Thursday after Health and Human Services Secretary Robert F. Kennedy Jr.

Concern is growing among public health experts that anti-vaccine sentiments within federal and state governments may derail ...

A purge of FDA staff spared some people tasked with responding to a judge’s orders to disclose government records on covid vaccines, according to agency employees. The FOIA litigation was brought by ...

The FDA has delayed granting full approval of Novavax's COVID-19 vaccine despite it being on track to be cleared until ...

Shuren, who retired from his spot leading the FDA’s Center for Devices and Radiological Health (CDRH) in 2024, said last week ...

WASHINGTON -- Shortly before he was forced to resign, the nation’s top vaccine regulator says he refused to grant Health ...

Right off the bat, the high-profile departure of Peter Marks, M.D., Ph.D., former director of the FDA’s Center for Biologics ...

More top vaccine regulators at the FDA have either left or been forced out, which could hobble the agency's ability to approve new vaccines and drugs.

The Pfizer/BioNTech bivalent COVID-19 vaccine (Original and Omicron BA.4/BA.5) has the FDA’s EUA for use in individuals 5 years and over as a single booster dose administered at least two months ...

The FDA has approved new versions of Pfizer/BioNTech's Comirnaty and Moderna's Spikevax COVID-19 vaccines that target the Omicron KP.2 strain of SARS-CoV-2 which was dominant in the US in recent ...