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 ...

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

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

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 ...

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

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 ...

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

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