After more than a month of speculation over how the FDA will rule on Novavax’s application for an updated formulation of its ...

The vaccine's prospects were thrown into doubt after the U.S. Food and Drug Administration missed its April 1 target to ...

The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.

If the FDA deems Pfizer’s and Moderna’s updated vaccines “new” products, it’s extremely unlikely the doses would be ready for ...

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

The plans amount to an extraordinary flex of Robert F. Kennedy Jr.’s power as health secretary to make decisions ordinarily ...

WASHINGTON (AP) — The Trump administration’s effort to impose new requirements on Novavax’s COVID-19 vaccine — the ... target — just like flu vaccines. The FDA was on track to grant ...

The Trump administration's effort to impose new requirements on Novavax's COVID ... to the flu shot, "which has been tried and tested for more than 80 years." Under federal law, the FDA is ...

WASHINGTON — The Trump administration’s effort to impose new requirements on Novavax’s COVID ... flu shot, “which has been tried and tested for more than 80 years.” Under federal law ...

The Novavax vaccine ... coronavirus continually mutates, manufacturers follow instructions from FDA to make one change each year to their recipe — which strain to target — just like flu ...