Novavax's full FDA approval for NUVAXOVID is a transformative milestone, unlocking a $175M Sanofi payment and validating ...

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine ...

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The Department of Disease Control warns of rising Covid-19 cases—nearly 50,000 last week—and expects the outbreak to continue for 2–3 months. Flu cases are steady with 300,000+ infections and 33 ...

Moderna, Inc. (Nasdaq:MRNA), today announced that in consultation with the U.S. Food and Drug Administration (FDA), the Company has voluntarily withdrawn the pending Biologics License Application (BLA ...

Top officials at the FDA outlined a new framework for approving Covid-19 vaccines, saying that the US would make the boosters available for Americans over the age of 65 and for adults and children ...

The FDA will make it more costly to seek approval of Covid-19 vaccines, but Moderna's shareholder reacted favorable to the ...

Changes are on the way for COVID vaccines after the FDA adjusted the standard of evidence needed to approve shots for the general public.

World Health Organization member countries on Tuesday approved an agreement to better prevent, prepare for and respond to ...

The Trump administration said Tuesday it will limit approval for seasonal COVID-19 shots to seniors and others at high risk ...

COVID-19 shots for healthy younger adults and children will no longer be routinely approved under a major new policy shift ...

Healthy adults younger than 65 will no longer be eligible for COVID-19 shots starting in the fall, according to new federal guidelines announced Tuesday.