The US FDA approved 46 new drugs in 2025, despite a tumultuous year at the regulatory agency.

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 ...

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 ...

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 strains 1 Shipping of the LP.8.1-adapted vaccine will ...

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 ...

The U.S. Food and Drug Administration issued its full approval of the Pfizer covid-19 vaccine Monday. The move comes eight months after the Pfizer vaccine was authorized for emergency use in the ...

The new vaccines, which target the omicron variant XBB.1.5, are approved for people 12 and older and are authorized under emergency use for children 6 months through 11 years old, according to an FDA ...

The ongoing Phase 3 clinical trial of Pfizer/BioNTech's coronavirus vaccine confirms its protection lasts at least six months after the second dose, the companies said Thursday. The companies can now ...

Madrigal has paid Pfizer $50 million for the rights to a DGAT2i inhibitor with the intention of combining the drug with its ...

The U.S. Food and Drug Administration has approved Pfizer's newest drug on the migraine market, Zavzpret (zavegepant) - the first and only migraine treatment of its kind to be offered in nasal spray.