Health secretary Robert F. Kennedy Jr. has expressed another unorthodox view on vaccines, declaring that single antigen ...

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

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

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

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

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

The delay follows leadership changes within the FDA. Dr. Scott Steele has been appointed acting director of the agency’s ...

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

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

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

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

The delayed decision comes amid a major organizational shakeup that included the departure of top vaccine official Peter ...