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FDA, Novavax and Covid

BioPharma Dive · 2h

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.

Novavax COVID Vaccine Moves Closer to Full FDA Approval

Under emergency use, vaccines can be removed even after a health emergency is considered to be over. Full approval from the FDA means a product can stay on the market even after a health emergency ends. (The World Health Organization declared an end to the COVID emergency in May 2023.)

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.

1hon 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 ...

6h

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 ...

35m

Nvidia & chip stocks falling, Novavax vaccine, Zscaler upgrade

Yahoo Finance host Julie Hyman takes a look at today's top moving stocks and biggest market stories in this segment of Market ...

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.

Zacks.com on MSN4d

Novavax (NVAX) Surges 19.5%: Is This an Indication of Further Gains?

Novavax (NVAX) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings ...

5d

Vertiv earnings beat, DOJ & Disney–fuboTV deal, Novavax COVID shot

Brad Smith outlines the top stories on Wall Street as part of Yahoo Finance's Market Minute. Vertiv Holdings (VRT) stock is ...

Novavax shares positive real-world results for JN.1-adapted COVID-19 vaccine

Novavax has shared positive preliminary results from a real-world study of its JN.1-adapted COVID-19 vaccine. The SHIELD-Utah ...

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