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 ...

The Food and Drug Administration on Tuesday named Dr. Vinay Prasad — a hematologist-oncologist who has been accused of ...

Vaccine maker Novavax is seeking to convert the 2022 emergency authorization of its Covid-19 vaccine into full approval. Yet ...

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

The advisory committee meeting is an important step in the process of readying boosters for the fall and winter season, but ...

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

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve ...

Leaders at the FDA, HHS and elsewhere are putting guardrails around COVID-19 boosters, which could mean delayed shots or ...

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

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

The U.S. Food and Drug Administration has named Vinay Prasad, an oncologist who has previously criticized FDA leadership and ...