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

The agency is sitting on a decision to grant full approval for Novavax’s shot, days after top vaccine regulator pushed out.

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

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

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

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 ...

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

The FDA was scheduled to release its decision on Novavax’s updated, protein-based COVID-19 vaccine on April 1, but the agency ...

After the gutting of the Department of Health and Human Services, fears mount about the future direction of the FDA—with ...

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 ...

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