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

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

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

The head of the U.S. Food and Drug Administration on Tuesday reportedly raised doubts about the need for COVID booster shots ...

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

"You could replace Peter Marks with a bobblehead doll that just stamps approval and you would have the same outcome at FDA ...

There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...

Dr. Vinay Prasad was an outspoken critic of the FDA’s response to the pandemic, including the former vaccine chief, Dr. Peter ...

Houston-based Empower Pharmacy has repeatedly been admonished by the FDA for failing to follow federal rules that ensure drug ...

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

The Food and Drug Administration (FDA) has tapped Vinay Prasad, a prominent critic of federal COVID-19 policies and a ...

Senior leaders at the FDA began pushing Moderna and Pfizer to file for full, formal approval of their COVID vaccines for ...