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

Moderna Inc. said it has “voluntarily” withdrawn its application for regulatory approval for its combination Covid and flu ...

Moderna has withdrawn its pending application for a combination vaccine for both the flu and Covid-19, saying it will resubmit later this year once it has more data.

We want to know more about what these products are doing,” said Dr. Vinay Prasad during a recent FDA livestreamed ...

The Food and Drug Administration is changing how it approves updated COVID-19 vaccines, limiting their availability to adults 65 and older and individuals with underlying health conditions. The agency ...

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine ...

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 ...

China continues to be a source of innovation as Pfizer strikes biggest pact yet; HHS provides more info on Trump’s Most Favored Nation executive order; FDA Commissioner Marty Makary and CBER director ...

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

Moderna, Inc. (Nasdaq:MRNA), today announced that in consultation with the U.S. Food and Drug Administration (FDA), 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.

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