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

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

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

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

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

Like FDA Commissioner Marty Makary and NIH Director ... sees as the limited evidence of their effectiveness. During the Covid-19 pandemic, he criticized the use of boosters in young people and ...

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

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

A new vaccine developed by Moderna aims to protect against both flu and COVID-19 with just one shot. Early studies suggest ...