Dr. Peter Marks, an ex-FDA vaccine official, is warning of a fundamental change at the agency—where vaccine skepticism now ...

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

The advisory committee, which met Tuesday for the first time since Robert F. Kennedy Jr. was sworn in as health secretary, ...

Officials at the Department of Health and Human Services have struggled to find records belonging to Dr. Tom Shimabukuro, the director of the CDC’s Immunization Safety Office.

The former top vaccines official at the Food and Drug Administration criticized Health and Human Services Secretary Robert F.

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

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

Novavax Inc. shares plunged as much as 26% after US Health and Human Services Secretary Robert F. Kennedy Jr. raised doubts ...

Marks said the delay to an approval decision on Novavax's COVID-19 vaccine, which was expected to be greenlighted earlier this month by the FDA, was concerning. And he warned that his own ouster ...

Arcturus Therapeutics Holdings Inc. ARCT announced that the FDA has granted a Fast Track designation to its self-amplifying ...

when pressed on why political appointees at the Food and Drug Administration delayed granting full approval to Novavax’s Covid-19 vaccine, which is currently under emergency use authorization.