In the wake of unprecedented workforce cuts at the FDA, former Commissioner Scott Gottlieb and an unnamed former CBER ...

“As of Tuesday, April 1, we had responded to all of the FDA’s information requests and we believe that our [Biologics License ...

Amid a period of great upheaval at the agency, the FDA has missed its deadline to decide on approval for Novavax’s COVID-19 ...

A top FDA official directly intervened in an agency review of Novavax’s Covid-19 vaccine, pausing the approval process to ask for more data on the shot, according to four people familiar with ...

Beyond the pending Novavax approval, the FDA must in the coming weeks advise Covid vaccine manufacturers on how to update their shots for the 2025-2026 respiratory season. The agency is also ...

Novavax started the week hoping the FDA would issue a full approval of its Covid vaccine. But the decision never came.

Novavax's COVID-19 vaccine received FDA Emergency Use Authorization, but full approval faces delays as regulators request ...

The U.S. Food and Drug Administration has missed its deadline for making a decision on traditional approval for Novavax's ...

The FDA was supposed to make a final decision about approval of Novavax's COVID-19 vaccine this week, but that deadline has ...

In an emailed statement to The Fly, Novavax (NVAX) said, “As we have previously stated, we believe that our Biologics License Application for ...

Novavax shifts to a partnership-focused strategy with a $500M Sanofi deal. Despite regulatory and competitive risks. See why ...

Vaccine maker Novavax's shares plunged nearly 20% at market close on Thursday, after Health and Human Services Secretary ...