Pfizer's CEO said Sunday that the company is "days" away from submitting data to the FDA in the hopes of having its COVID-19 vaccine approved for children as young as 5. In speaking ABC News on Sunday ...

Pfizer and BioNTech said Monday they have submitted early stage clinical trial data to the Food and Drug Administration as part of their U.S. application seeking authorization of a Covid vaccine ...

NEW YORK, N.Y. — Pfizer and BioNTech announced Friday that they’re submitting new data to the Food and Drug Administration (FDA) that shows their COVID-19 vaccine can be stored at higher temperatures, ...

The FDA staff made the conclusion in briefing documents ahead of a meeting on Thursday when a panel of external advisors to the agency will discuss whether to recommend full approval of the RSV shot.

NEW YORK - Pfizer on Wednesday shared data about a third dose of its COVID-19 vaccine that suggests it "strongly" boosts protection against the more contagious delta variant of the coronavirus, which ...

U.S. scientists and regulators told Pfizer July 12 that they need more data and more time to determine if COVID-19 vaccine booster shots are necessary, The New York Times reported. Pfizer ...

A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. This story was originally published on BioPharma Dive. To receive daily news ...