Posts Tagged: Biologics

Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to: Expand the use of a single…

Coronavirus (COVID-19) Update: December 17, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On December 15, 2021,…

Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster…

Coronavirus (COVID-19) Update: FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters

As we have with previous emerging COVID-19 variants, the U.S. Food and Drug Administration is actively working with our federal partners, international regulators and medical…

Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a…

Coronavirus (COVID-19) Update: November 5, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Today, Friday, November 5,…

Coronavirus (COVID-19) Update: November 2, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On Friday, October 22,…

Coronavirus (COVID-19) Update: October 29, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On Friday, October 22,…

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age

Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5…

Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines

Today, the U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency…