Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine.

Novavax stock was climbing again on Monday after the company expressed new confidence in the eventual approval of its ...

The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 ...

“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to ...

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

Novavax's COVID vaccine was approved under an emergency use authorization in August 2022, and the company has pursued full ...

01. Confusion over the Food and Drug Administration’s delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend when the agency’s commissioner, Marty Makary ...

Thousands of Americans campaigning for the Novavax COVID-19 booster got some good news this week: the FDA signaled it might ...

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve COVID-19 vaccines for next winter, citing a lack of data on booster shots.

WASHINGTON (AP) — The Trump administration’s effort to impose new requirements on Novavax’s COVID-19 vaccine — the nation’s only traditional protein-based option for the coronavirus ...

In his weekend tweet, FDA’s Makary referred to the Novavax vaccine as “a new product,” presumably because it had been updated to match last year’s common coronavirus strain. “New ...