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Topic: SARS-CoV-2

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – Today, May 10th, 2021,  the U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age.

COVID-19 Coronavirus Vaccine

COVID-19 Coronavirus Vaccine

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

 

U.S. Food and Drug Administration (FDA)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:

COVID-19 Coronavirus

COVID-19 Coronavirus

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President Joe Biden’s Proclamation on Suspension of Entry as Nonimmigrants of Certain Additional Persons Who Pose a Risk of Transmitting COVID-19

 

The White HouseWashington, D.C. – The national emergency caused by the coronavirus disease 2019 (COVID-19) outbreak in the United States continues to pose a grave threat to our health and security. 

As of April 29th, 2021, the United States had experienced more than 32 million confirmed COVID-19 Coronavirus cases and more than 570,000 COVID-19 Coronavirus deaths.  It is the policy of my Administration to implement science-based public health measures, across all areas of the Federal Government, to act swiftly and aggressively to prevent further spread of the disease.

United States President Joe Biden.

United States President Joe Biden.

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FDA, CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Coronavirus Vaccine in the U.S. should be lifted and use of the vaccine should resume.

COVID-19 Coronavirus Vaccine

COVID-19 Coronavirus Vaccine

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FDA Coronavirus (COVID-19) Update: Emergency Use Authorization issued for Symbiotica COVID-19 Self-Collected Antibody Test System

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced it has issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples. Samples collected at home are then sent to a Symbiotica, Inc. laboratory for analysis.

COVID-19 Coronavirus

COVID-19 Coronavirus

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FDA Coronavirus (COVID-19) Update: March 27th, 2021

 

U.S. Food and Drug Administration (FDA)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:

On March 23rd, 2021, the FDA issued an emergency use authorization (EUA) to the Twist Bioscience Corporation for their SARS-CoV-2 NGS Assay.

COVID-19 Coronavirus

COVID-19 Coronavirus

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FDA Coronavirus (COVID-19) Update: March 21th, 2021

 

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

On March 16th, the FDA posted a new web page on FDA.gov, Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs.

COVID-19 Coronavirus

COVID-19 Coronavirus

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Coronavirus (COVID-19) Update: FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies.

Coronavirus

Coronavirus

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FDA Coronavirus (COVID-19) Update: FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test

 

U.S. Food and Drug Administration (FDA)Washington D.C. – The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use.

The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription.

Coronavirus.

Coronavirus.

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FDA Issues Emergency Use Authorization for Janssen COVID-19 Vaccine

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – Today, February 27th, 2021,  the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the United States for use in individuals 18 years of age and older.

COVID-19 Coronavirus Vaccine

COVID-19 Coronavirus Vaccine

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