Vaccine maker Novavax stock jumped double digits on Thursday after the company reported its quarterly sales had more than ...

Novavax on Thursday tried to calm investors spooked by the delay of full approval of its COVID vaccine shot by U.S. regulators saying that it sees a pathway to resolving issues with the FDA, sending ...

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

Novavax said on Thursday discussions with the U.S. health regulator on its COVID-19 shot are ongoing and a pathway to ...

Officials in sixteen states and the District of Columbia sued in response, leading to Tuesday’s order from U.S. District ...

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

A blanket requirement for placebo-controlled trials threatens research ethics and vaccine access, it’s being argued.

Yes, according to leading vaccine physician Paul Offit, who denounced the new placebo-controlled trial requirements for ...

The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.

If the FDA deems Pfizer’s and Moderna’s updated vaccines “new” products, it’s extremely unlikely the doses would be ready for ...

The US Department of Health and Human Services said Thursday that it aims to accomplish within four years a scientific feat ...

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.