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FDA Again Scrutinizes Novavax Covid-19 Vaccine

The Associated Press on MSN · 12h

FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots

There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from Novavax

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 · 2d

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.

21h

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 ...

FDA Alumni, Experts Call on Makary To Stand Up Against Agency’s Politicization

In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions ...

5don MSN

Novavax shares soar after FDA request raises hope for COVID vaccine approval

Novavax said on Wednesday U.S. regulators asked the company to produce more data on its COVID-19 vaccine if it gets full ...

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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