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

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

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

Here are eight possible indicators of how health secretary Robert F. Kennedy Jr. may handle U.S. vaccine policy in coming ...

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

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

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

The President Donald Trump administration's request for Novavax Inc. to conduct new clinical trials for its COVID-19 vaccine ...

Under emergency use, vaccines can be removed even after a health emergency is considered to be over. Full approval from the ...

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.

In addition, HHS Secretary Robert F. Kennedy Jr addressed the delay in Novavax's approval in a CBS interview earlier this ...

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