On Monday morning, the FDA gave full approval to the Pfizer covid-19 vaccine. This is an even faster approval than Pfizer has hoped for, as the most optimistic date had been early September. Until now ...

The US saw several new and expanded FDA indications this year. The top 5 most-read FDA approvals on AJMC.com included 4 novel therapies and 1 expanded indication, reflecting the growing number of ...

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 company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.

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 FDA is considering changes that could reshape how vaccines move from labs to American pharmacies — the most significant proposed shift in vaccine oversight since the early 2000s. While the agency ...

A rare but severe stem cell transplant complication that often becomes fatal now has its first FDA-approved treatment, a therapy developed by biotechnology company Omeros. The Christmas Eve regulatory ...