FDA approves Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 -11

Silver Spring, MD – Today, Friday, October 29th, 2021,  the U.S. Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 Coronavirus to include children 5 through 11 years of age.

The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.

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FDA Approves First COVID-19 Vaccine, Pfizer-BioNTech

Silver Spring, MD – Today, Monday, August 23rd, 2021, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.

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CDC, FDA release Joint Statement on Vaccine Boosters

Silver Spring, MD – The United States is fortunate to have highly effective vaccines that are widely available for those aged 12 and up. People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta.

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FDA Coronavirus (COVID-19) Update: May 1st, 2021

Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

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FDA Issues Emergency Use Authorization for First COVID-19 Vaccine

Silver Spring, MD – The U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the United States.

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FDA Statement on Vaccines, Related Biological Products Advisory Committee Meeting

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

Silver Spring, MD – Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 Coronavirus vaccine, the U.S. Food and Drug Administration (FDA) has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.

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FDA Coronavirus (COVID-19) Update: November 24th, 2020

Silver Spring, MD – The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 Coronavirus pandemic:

On November 20th, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

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FDA Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

Silver Spring, MD – The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 Coronavirus in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

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FDA Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Pfizer COVID-19 Vaccine Candidate

Silver Spring, MD – The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 10th, 2020 to discuss the request for emergency use authorization (EUA) of a COVID-19 Coronavirus vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.

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FDA Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home

Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first COVID-19 Coronavirus diagnostic test for self-testing at home and that provides rapid results.

The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 Coronavirus.

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