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Novavax, FDA and Covid

BioPharma Dive · 31m

Novavax says vaccine application still ‘approvable,’ despite FDA delay

Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” requiring additional clinical study.

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.

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

Novavax: Grandiose Ambitions, Smart Strategy, But FDA Decision Adds To Challenges

Novavax shows financial improvement but faces vaccine challenges. Read why I rated NVAX stock as 'Hold' and what risks and ...

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 ...

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