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Novavax, Covid-19 and FDA

CNN on MSN · 1d

FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval

The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 vaccine as a post-approval commitment, a source familiar with the matter told CNN.

Reuters on MSN · 2d

US FDA asks Novavax to complete new clinical trial for delayed COVID-19 shot, WSJ reports

Federal regulators have asked Novavax to complete an additional clinical trial on its COVID-19 vaccine after previously delaying approval, the Wall Street Journal reported on Friday, citing people familiar with the matter.

Bloomberg on MSN · 2d

Novavax Falls on Report That FDA Wants New Covid Vaccine Trial

Novavax Inc. shares fell after the Wall Street Journal reported that US regulators asked the company to conduct another clinical trial of its Covid vaccine.

4h

FDA’s job cuts paint mixed picture for drugmaker’s R&D plans

After a 20% cut to the FDA’s workforce, biotechs and pharmas are bracing for delays. But the impacts won’t be consistent.

2don MSN

FDA asks Novavax to complete new clinical trial for delayed COVID-19 shot, WSJ reports

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

U.S. health officials inject new uncertainty into approval process for Covid boosters

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

Novavax shares positive real-world results for JN.1-adapted COVID-19 vaccine

Novavax has shared positive preliminary results from a real-world study of its JN.1-adapted COVID-19 vaccine. The SHIELD-Utah ...

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