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

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

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

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

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

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

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

But the FDA and the Centers for Disease Control and Prevention (CDC) released a safety notice on May 9 recommending that adults over 60 years old pause use of the vaccine due to fatal complications.

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

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

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

According to approval letter, the license restricts the use of vaccine called Nuvaxovid to individuals aged 65 and older, and ...