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.

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

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

Overall, the hazard ratio for in-hospital mortality at 28 days was 0.73 (95% confidence interval, 0.56 to 0.96) compared to ...

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

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

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

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

Dr. Vinay Prasad, the FDA's new vaccine chief, has been accused of spreading misinformation about Covid vaccines.

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

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