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New COVID-19 Vaccine on Track for FDA Approval

CNN on MSN · 9h

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.

FDA still negotiating whether to grant full approval to Novavax COVID-19 vaccine

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

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.

After Missed Decision Deadline, Novavax Says COVID-19 Shot ‘Approvable’

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

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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