After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter ...

Novavax originally showed its vaccine was safe and effective in a 30,000-person clinical trial. The FDA had been on track to ...

The U.S. Food and Drug Administration (FDA) on Friday approved Novavax's Covid-19 vaccine, but placed additional conditions ...

FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...

The agency narrowed who can get the shot and added new study requirements that could cost the company tens of millions.

Another Breakthrough Summit West in the books, and what an excellent event! We kicked off the day with former FDA head Robert ...

Adults over the age of 60 are recommended not to get the chikungunya vaccine to prevent the mosquito-borne illness due to two ...

A top agency official is meeting with industry and FDA staff as he works on guidance clarifying the FDA’s expectations for ...

The US Food and Drug Administration has named Dr. Vinay Prasad, a hematologist oncologist, to lead its Center for Biologics ...

An FDA advisory committee is scheduled to meet to discuss the formula for the next COVID-19 vaccines after being sidelined ...

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

The CDC recommends the vaccine pause while it investigates “serious adverse events,” including neurologic and cardiac events.