Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

The U.S. Food and Drug Administration said on Wednesday it will hold a meeting of experts on May 22 to discuss COVID-19 ...

Vinay Prasad, named to lead the FDA agency tasked with regulating vaccines and gene therapy, has made controversial comments ...

Novavax on Thursday tried to calm investors spooked by the delay of full approval of its COVID vaccine shot by U.S.

A half-decade since the pandemic, countless individuals and families have been left wondering: what is the long-term safety ...

For years, U.S. vaccine experts have issued a universal recommendation for Covid vaccines. That could change soon.

The US Food and Drug Administration has named Dr. Vinay Prasad, a hematologist oncologist, to lead its Center for Biologics ...

The Food and Drug Administration says that a prominent medical contrarian and critic of the drug industry will head its ...

The plans amount to an extraordinary flex of Robert F. Kennedy Jr.’s power as health secretary to make decisions ordinarily ...

In his new role with the FDA, Dr. Vinay Prasad will oversee the regulation of costly drugs, including vaccines, gene ...

If the FDA deems Pfizer’s and Moderna’s updated vaccines “new” products, it’s extremely unlikely the doses would be ready for ...

Momentum is building to scale back the current recommendation that all children over 6 months old get immunized against the ...