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

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 shows financial improvement but faces vaccine challenges. Read why I rated NVAX stock as 'Hold' and what risks and ...

Novavax Inc. shares fell after the Wall Street Journal reported that US regulators asked the company to conduct another ...

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

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

A new randomized study could cost Novavax tens of millions of dollars, vaccine experts say ...

Novavax's protein-only vaccine is once again expected to move from emergency approval to full approval status following a pause.

Federal regulators have asked Novavax to complete an additional clinical trial on its COVID-19 vaccine after previously ...

Confusion over the FDA delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend, with possible ...

Several current and former FDA employees who spoke to Inside Medicine on the condition of anonymity have come to see the ...