America’s drug safety agency declined to review a next-gen flu vaccine that uses the same tech as the coronavirus shots ...

Experts say ‘they’re just coming up with reasons’ as agency says application lacked ‘adequate and well controlled’ trial ...

PHILADELPHIA (WPVI) -- The FDA has authorized the Pfizer vaccine for kids ages 12 to 15. The CDC still has to give its stamp of approval, but if everything goes as expected, we could see more kids in ...

The US Food and Drug Administration has issued emergency use authorization (EUA) for the Covid-19 vaccine developed by Pfizer and BioNTech. After months of development, emergency use was authorized ...

On Tuesday, a key Food and Drug Administration (FDA) panel voted to formally recommend that children as young as 5 be authorized to receive Pfizer's COVID-19 vaccine under emergency use authorization.

PHILADELPHIA -- Pfizer and BioNTech said Tuesday they have submitted Covid-19 vaccine data on children ages 5 to 11 to the US Food and Drug Administration for initial review, but are not yet seeking ...

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu ...

WASHINGTON -- Pfizer announced Friday that it submitted a request to the U.S. Food and Drug Administration to allow emergency use of its COVID-19 vaccine to children as young as 12. This is the next ...

Pfizer/BioNTech has initiated its application to the US Food and Drug Administration for full FDA approval of its Covid-19 vaccine for people ages 16 and older, the companies said Friday. This is the ...

WASHINGTON — Pfizer and Moderna say the Food and Drug Administration have opened up COVID-19 booster shots to all adults, letting them choose another dose of either vaccine. The move expands the ...