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

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

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

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

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 ...

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

WASHINGTON — Novavax's closely watched COVID-19 vaccine is on track for full approval after additional discussions with the ...

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

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

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

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