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

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.

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 ...

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

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

"As of Tuesday, April 1, we had responded to all of the FDA's information requests and we believe that our is ready for approval," Novavax said in a statement, noting that the application ...

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

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