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

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

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

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

Novavax has been available since 2022 through a pandemic-era Emergency Use Authorization. A decision on full approval – which ...

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

At FDA, full vaccine approval is the gold standard. The agency was on track to sign off on Novavax’s license by its April 1 ...

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

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

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

(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 ...