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Topic: Antibody

FDA Coronavirus (COVID-19) Update: August 8th, 2020

 

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

On August 6th, the FDA revoked the emergency use authorization (EUA) for Autobio Diagnostics Co., Ltd.’s, Anti-SARS-CoV-2 Rapid Test, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test.

Coronavirus.

Coronavirus.

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FDA Coronavirus (COVID-19) Update: August 4th, 2020

 

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:

Coronavirus

Coronavirus

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Coronavirus (COVID-19) Update: FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) authorized the first two COVID-19 Coronavirus serology tests that display an estimated quantity of antibodies present in the individual’s blood.

Coronavirus

Coronavirus

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President Donald Trump to recovered Coronavirus Patients, Your plasma could save lives

 

The White HouseWashington, D.C. – President Donald Trump just visited the American Red Cross Headquarters, where he joined public health experts from across the government to discuss a promising new development in the fight against COVID-19 Coronavirus.
 
New research shows that the plasma from recovered COVID-19 Coronavirus patients could help those who are currently battling the disease. The Red Cross and America’s Blood Centers together will receive up to $270 million from the Administration for the collection of up to 360,000 units of plasma for this purpose.

President Donald Trump participates in a tour of the Red Cross National Headquarters. (White House)

President Donald Trump participates in a tour of the Red Cross National Headquarters. (White House)

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FDA Coronavirus (COVID-19) Update: June 17th, 2020

 

U.S. Food and Drug Administration (FDA)Silver Spring, MDThe U.S. Food and Drug Administration is taking action in the ongoing response to the COVID-19 Coronavirus pandemic:

The FDA posted a new web page, Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents.

Coronavirus

Coronavirus

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FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord

 

U.S. Food and Drug Administration (FDA)Silver Spring, MDThe U.S. Food and Drug Administration (FDA) has approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients with a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody positive).

Second FDA Approved Therapy for Neuromyelitis Optica Spectrum Disorder Offers Patients Additional Treatment Option.

Second FDA Approved Therapy for Neuromyelitis Optica Spectrum Disorder Offers Patients Additional Treatment Option.

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Coronavirus (COVID-19) Update: FDA Publicly Shares Antibody Test Performance Data From Kits as Part of Validation Study

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration publicly posted test performance data from four more antibody, or serology, test kits on open.fda.gov from its independent performance validation study effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI).

Coronavirus

Coronavirus

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FDA Coronavirus (COVID-19) Update: June 6th, 2020

 

U.S. Food and Drug Administration (FDA)Silver Spring, MDThe U.S. Food and Drug Administration (FDA), Friday, May 5th, 2020, continued to take action in the ongoing response to the COVID-19 Coronavirus pandemic:

The FDA issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures and highlights of the agency’s response efforts.

Coronavirus.

Coronavirus.

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FDA Coronavirus (COVID-19) Update: June 5th, 2020

 

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

Today, the FDA issued a new video resource explaining the different categories of tests in the fight against COVID-19 Coronavirus: diagnostic tests and antibody tests.

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Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.

Coronavirus.

Coronavirus.

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