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 ...

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

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

The head of the FDA reiterated that the agency is applying a more skeptical approach to this year’s round of COVID-19 vaccine boosters.

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

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

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

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

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

In a statement today, the company said it supports recent precautionary measures and that thorough investigations are needed ...