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FDA Again Scrutinizes Novavax Covid-19 Vaccine

The Associated Press on MSN · 13h

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.

More FDA uncertainty roils full approval for Novavax COVID vaccine

Novavax's COVID vaccine was approved under an emergency use authorization in August 2022, and the company has pursued full licensing with the Food and Drug Administration (FDA), which gave the company a decision date of April 1 based on the Prescription Drug User Fee Act.

NBC 7 San Diego20h

FDA appears to be slow-walking vaccine approvals

Dr. Marty Makary, the FDA’s commissioner, said the company is asking the agency to approve “a new product” based on old ...

22h

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 ...

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 ...

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.

5d

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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