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New COVID-19 Vaccine on Track for FDA Approval

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

As FDA delays Novavax' COVID vaccine approval, patients fight back

By Julie Steenhuysen CHICAGO (Reuters) -Thousands of Americans campaigning for the Novavax COVID-19 booster got some good news this week: the FDA signaled it might still win approval after Health Secretary Robert F.

The Wall Street Journal on MSN · 11h

FDA Asks Vaccine Maker to Complete New Clinical Trial for Delayed Covid-19 Shot

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

Fierce Pharma2d

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 ...

12h

Novavax (NasdaqGS:NVAX) Announces Positive SHIELD-Utah Study Results

Novavax (NasdaqGS:NVAX) recently announced preliminary results from its SHIELD-Utah study, showcasing the Novavax COVID-19 vaccine's effectiveness and reduced side effects compared to a competitor's ...

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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New COVID-19 Vaccine on Track for FDA Approval

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