Posts Tagged: Biologics

FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children

Today, the U.S. Food and Drug Administration is announcing two upcoming meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly…

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

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

Coronavirus (COVID-19) Update: September 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 Sept. 17, the…

Coronavirus (COVID-19) Update: September 10, 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, the FDA posted…

FDA Will Follow The Science On COVID-19 Vaccines For Young Children

As schools around the country are re-opening for in-person learning and families are returning to their busy school year schedules, we know many parents are…

FDA In Brief: FDA to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTech’s Application for COVID-19 Booster

The following quote is attributed to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Research and Evaluation: “The administration recently announced a…

Coronavirus (COVID-19) Update: August 24, 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 Aug. 22, the…

FDA Approves First COVID-19 Vaccine

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now…

Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots

Español Today, public health and medical experts from the U.S. Department of Health and Human Services (HHS) released the following statement on the Administration’s plan…

Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals

On Fri., Aug. 13, 2021, the Centers of Disease Control and Prevention’s Advisory Committee on Immunization Practices outlined clinical recommendations  regarding an additional dose of…