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

Health Secretary Robert F. Kennedy Jr. called for people to get the measles vaccine, while falsely claiming it has not been ...

The Food and Drug Administration (FDA) announced Thursday it plans to phase out animal testing requirements for biological ...

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

Vaccination campaigns have nearly eradicated some of the most deadly and transmissible diseases. In a rising tide of vaccine ...

Concern is growing among public health experts that anti-vaccine sentiments within federal and state governments may derail ...

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

As the respiratory syncytial virus (RSV) vaccine field grapples with a significantly reduced market size thanks to regulatory ...

More top vaccine regulators at the FDA have either left or been forced out, which could hobble the agency's ability to ...

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