The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine — the nation's only traditional ...

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

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

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

Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the ...

Novavax said on Wednesday U.S. regulators asked the company to produce more data on its COVID-19 vaccine if it gets full ...

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

Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...

The new policy, revealed by the Department of Health and Human Services on Wednesday, would make vaccines “less available and ...

The anticipated rollout of updated Covid vaccines this fall might be at risk after a change by Health and Human Services ...

Novavax has been available since 2022 through a pandemic-era Emergency Use Authorization. A decision on full approval – which ...

The potential change outlined in a statement would require all new vaccines to undergo placebo testing, sparking concerns ...