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FDA Authorizes Monoclonal Antibody for Treatment of COVID-19

FDA Authorizes Monoclonal Antibody for Treatment of COVID-19

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 …

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FDA Now Approves Expanded Plasma Treatment After Halt

FDA Now Approves Expanded Plasma Treatment After Halt

Just days after putting a halt on the expanded emergency use of plasma to treat COVID-19 patients due to efficacy concerns and the data behind it cited by Dr. Fauci, Dr. Lane and Dr. Collins, prompting a stronger review of the available data, the FDA has now given the emergency use approval for the expanded …

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FDA Stops Emergency Approval For Use Of Blood Plasma In Covid-19

Plasmapheresis

The FDA was in the process to allow the emergency use of blood plasma donation from those who have recovered from COVID-19. However, this authorization has been put hold as they are reviewing more data. Officials say that the emergency approval could still be issued in the future, but not at this time, as quoted …

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Rapid Antigen Test For COVID-19 Authorized By FDA

Rapid Antigen Test For COVID-19 Authorized By FDA

The US FDA has granted an emergency use authorization to Becton Dickson and CO for a rapid COVID-19 antigen test that can be administered at the point of care to produce results within 15 minutes; and in early trading shares for the company have increased $5.40 which is about 2.3%. Antigen testing works by scanning …

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FDA Repeals Emergency Authorization Use Of Chloroquine & Hydroxychloroquine

FDA Warning Notification On Exosome Products

The FDA has revoked the EUA granted to the antimalarial drugs chloroquine phosphate and the less toxic metabolite hydroxychloroquine sulfate for treatments against COVID-19, this repeal cites a lack of consistent replication of earlier results and a randomized clinical trial that showed no benefit. The drugs have become a popular topic of discussion after being …

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