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FDA, Novavax and COVID-19

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.

Infectious Disease Advisor · 5h

Novavax COVID-19 Vaccine Moves Closer to Full FDA Approval

Novavax’s COVID-19 vaccine could soon receive full approval from the United States Food and Drug Administration.

The Wall Street Journal on MSN · 2d

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

17mon MSN

Novavax Stock Is Up Again. There Are Still Big Questions About the Fate of Its Covid Shot.

Novavax said Monday morning that the Food and Drug Administration was asking the company to run a new trial of its Covid-19 ...

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 ...

5h

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 ...

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 ...

5d

RFK Jr. could pull Covid vax for kids

HHS Secretary Robert F. Kennedy Jr. is mulling removing the Covid-19 vaccine from the recommended childhood vaccine schedule.

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