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Novavax, COVID-19 and FDA

The Associated Press on MSN · 7h

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

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.

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.

7hon MSN

FDA appears to be slow-walking vaccine approvals

Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...

10h

Under Trump, the FDA may no longer approve seasonal COVID shots

Under President Trump, the Food and Drug Administration may no longer approve seasonal COVID-19 vaccines updated for the ...

Pharmalittle: We’re reading about tariffs increasing U.S. drug costs, Trump cuts on drug safety, and more

Analysis found 25% tariff on pharmaceutical imports would hike U.S. drug costs by nearly $51 billion annually, boosting ...

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 ...

17h

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 ...

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