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Novavax, Covid-19 and FDA

CNN on MSN · 22h

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 · 1d

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 · 1d

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.

Fierce Pharma3d

FDA asks Novavax for post-marketing data pledge amid stalled COVID shot review

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

Novavax Booster's Fate in Limbo: FDA Considers Approval Amid Controversy

The FDA is considering the approval of the Novavax COVID-19 booster after delays amid controversy over its non-mRNA design.

3d

Novavax's stock surges on 'good news' from Food and Drug Administration

Novavax’s protein-based vaccine is only available under a pandemic-era emergency-use authorization, and formal approval from ...

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