So that’s the path to emergency authorization, which Pfizer received in December. Since then, per the standard FDA approval process, the drug maker has kept track of any serious side effects ...

After the U.S. Food and Drug Administration gave its official stamp of approval to the Pfizer-BioNTech COVID-19 shot, some social media users tried to dismiss it by pointing to other products the ...

The external expert committee will review data from Pfizer and German startup BioNTech on their vaccine, called BNT162b2, and by day's end will vote whether the U.S. Food and Drug Administration ...

Pfizer submitted a New Drug Application for Paxlovid, its oral antiviral COVID-19 treatment, on June 30. The drug, which already has received emergency approval by the FDA, reduces the risk of ...

For its approved uses, the drug accounted for $437 million in revenue for the nine months ended Sept. 30, 2024, a 26% increase compared to the same period in the prior year, according to Pfizer ...

Alnylam Pharmaceuticals Inc. won expanded US approval for a heart drug that could be the biggest boon yet for the 23-year-old biotech — if it can beat out stiff competition from the likes of ...

The US Food and Drug Administration granted full approval this week for the Pfizer/BioNTech Covid-19 vaccine for people 16 years of age and older. This is the first of the coronavirus vaccines to ...

Pfizer-BioNTech is seeking the Food and Drug Administration's approval for its COVID-19 vaccine, with the goal of getting the agency's green light "in the coming months." ...

On Monday morning, the Food and Drug Administration (FDA) granted full approval to the first Covid-19 vaccine — a significant milestone in the ongoing fight to end the pandemic.

Approval for Pfizer's two-dose vaccine was originally scheduled for Labor Day but was moved up due to a ... “We expect the Food and Drug Administration to approve one or more COVID-19 vaccines ...

The Food and Drug Administration has given full approval to the Pfizer COVID-19 vaccine. The highly anticipated decision could give the nation's vaccination campaign a badly needed boost.