Sep 23, 2021 | News, Regulatory
Pfizer-BioNTech has been granted FDA (Food and Drug Administration) authorization for its booster shot for people aged 65 and older, as well as individuals at high risk for severe disease and those working in patient-facing healthcare, six months are their second...
May 11, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer and BioNTech COVID-19 vaccine to now include young teens between 12 and 15 years of age. Previously, the EUA was approved for patients 16 years of age and older,...
Dec 31, 2020 | News, Regulatory
According to Operation Warp Speed Chief, Moncef Slaoui, the AstraZeneca and Oxford University vaccine may not receive the U.S. Food and Drug Administration’s Emergency Use Approval (EUA) until April, despite the UK’s approval yesterday (12/30). Questions...
Dec 14, 2020 | News, Regulatory
Pfizer and BioNTech have made history with their COVID-19 vaccine, as it is the first to enter the U.S. market after Phase 3 clinical trial results showing 95% efficacy. The mRNA vaccine is being allocated for emergency use to hospitals nationwide,...
Aug 7, 2020 | News, Regulatory
Pfizer announced today (8/7) that it has signed a multiyear agreement for Gilead’s remdesivir, a treatment for Covid. With Gilead aiming to produce enough remdesivir to treat more than 2 million patients by the end of the year, and agreeing to send almost the entirety...
