The Food and Drug Administration has approved the Novavax COVID-19 vaccine—with strict conditions. Coming after four years of ...

The Food and Drug Administration has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual ...

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 on Friday approved Novavax's COVID-19 vaccine, but placed additional conditions on ...

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.

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

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

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

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

Dr. Vinay Prasad was an outspoken critic of the FDA’s response to the pandemic, including the former vaccine chief, Dr. Peter ...