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

The U.S. Food and Drug Administration (FDA) is still negotiating whether to grant full approval to Novavax's COVID-19 vaccine ...

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

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

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

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

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

On a recent call with analysts at BMO Capital Markets, a “former director” at the FDA’s Center for Biologics Evaluation and ...

Novavax announced that it's COVID-19 vaccine could get full approval from the U.S. Food and Drug Administration soon.The ...

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

The FDA is asking Novavax for a non-mandatory postmarketing commitment to produce additional clinical data for its ...

The terms need to be negotiated before Novavax’s vaccine could be granted full approval, the source said, declining to be named because they weren’t authorized to speak on behalf of the FDA.