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Novavax shares jump after long-awaited FDA approval of its COVID-19 vaccine
Novavax shares jumped more than 15% on Monday after the company secured a long-awaited U.S. regulatory approval for its COVID ...
After delay, FDA approves Novavax’s Covid-19 vaccine, but only for older people and those at high risk
After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter ...
Novavax: Nuvaxovid FDA Approval Unlocks Several Bullish Stimuli
Novavax's full FDA approval for NUVAXOVID is a transformative milestone, unlocking a $175M Sanofi payment and validating ...
STAT6d
Novavax wins narrowed approval for its Covid-19 shot after delay
Covid shots are facing greater scrutiny from top federal health officials like RFK Jr. and the FDA's Marty Makary.
BioPharma Dive6d
Novavax’s COVID vaccine gets FDA approval, but with limits
While the clearance is only for use in certain groups, Novavax’s long-awaited OK is still seen by analysts as a “win” for the ...
BioSpace6d
FDA Grants Narrow Approval of Novavax’s COVID Shot as Makary Teases Changes to Vaccine Approval Framework
The restrictions on Novavax's vaccine could portend changes at the FDA. Commissioner Marty Makary suggested last week that ...
FDA sets new COVID booster guidelines for healthy adults under 65
The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.
STAT5d
When the FDA requires a large vaccine trial, who pays?
In the Phase 2 study of patients with chronic kidney disease, the highest dose of the drug lowered by 86% the levels of ...