Pfizer Gets FDA Priority Review for Expanded Hympavzi Approval

Pfizer has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its Hympavzi hemophilia drug for two patient populations with significant medical need ...
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Pfizer and BioNTech begin application for full FDA approval of their COVID-19 vaccine

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 ...

Pfizer wins FDA priority review for Hympavzi label expansion

Pfizer (PFE) announced on Friday that the U.S. Food and Drug Administration granted priority review for a marketing ...
The Pharma Letter

FDA grants priority review for Hympavzi sBLA

Pfizer today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for the ...
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Pfizer and BioNTech’s COMIRNATY® Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19

The 2025-2026 COVID-19 vaccine formulation targets the SARS-CoV-2 sublineage LP.8.1, in line with FDA guidance to more closely match circulating strains1 Shipping of the LP.8.1-adapted vaccine will ...
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What parents need to know following FDA's authorization of Pfizer vaccine for ages 12-15

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 ...
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FDA issues emergency approval Pfizer's COVID-19 vaccine for kids as young as 5

WASHINGTON — The FDA on Friday issued emergency approval for a smaller dose version of Pfizer's COVID-19 vaccine for use in children aged 5 to 11. The agency's decision comes just days after the ...