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PharmExec1d
FDA Grants Full Approval to Novavax’s Nuvaxovid COVID-19 Vaccine
Previously granted Emergency Use Authorization, Nuvaxovid is now available for individuals over 12 years of age.
Who can get updated COVID vaccines this fall? FDA will OK for high-risk groups, calls for new clinical trials
The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at ...
Clinical Advisor8h
FDA Approves Novavax’s COVID-19 Vaccine Nuvaxovid
The FDA also requested Novavax conduct a phase 4 study in patients aged 50 to 64 years without high-risk conditions for severe COVID-19.
F.D.A. Approves Novavax Covid Vaccine With Stricter New Conditions
The agency narrowed who can get the shot and added new study requirements that could cost the company tens of millions.
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 ...
MPR7h
FDA’s New COVID-19 Vaccine Approval Policy May Limit Future Access
According to Makary and Prasad, the US’s adoption of a “one-size-fits-all” guidance for COVID-19 vaccination departs from ...
FDA’s new approach raises questions about fall COVID vaccine availability
Health experts say there are legitimate questions about how much everyone still benefits from yearly COVID vaccination or ...
Healthy Returns: Novavax scores narrower Covid vaccine approval after delay
Novavax can finally breathe a sigh of relief – at least a small one. The Food and Drug Administration approved the company's ...
FDA Announces Major Overhaul of COVID-19 Vaccine Strategy
The U.S. Food and Drug Administration (FDA) is changing the game on COVID-19 vaccines. Instead of approving yearly boosters ...
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.