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U.S. FDA Authorizes Regeneron’s REGN-COV2 Monoclonal Antibody for Emergency Use Authorization Targeting Select COVID-19 Patients

The monoclonal antibody cocktail developed by Regeneron and made well-known by POTUS during his stay at Walter Reed Medical Center has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Initially called REGN-COV-2 and also...

POTUS Accuses FDA of “Politics” In Vaccine-Approval Process, But FDA’s Mandate is a Political Decision to Remain The Gold Standard for Safety

On Wednesday, US President Donald Trump suggested that the recent initiative by the FDA to tighten-up COVID-19 vaccine guidelines was politically-motivated. More specifically, POTUS declared, “That sounds like a political move.” With an imminent election,...

Lilly on the Verge of COVID-19 Monoclonal Antibody EUA Approval First for High Risk Patients with Recent Mild-to-Moderate COVID-19 Diagnosis

TrialSite shared that Eli Lilly’s (Lilly) monoclonal antibody program targeting COVID-19 appeared to be working, at least according to some trial site reports. Now Lilly is moving to secure an emergency use authorization for its monotherapy (LY-CoV555) to the U.S....

COVID-19 & the Disruption of Clinical Trials Worldwide: Readjustment in the Works

With long-lasting effects on medical science, reports Aaron van Dorn, the COVID-19 pandemic has created massive disruptions to clinical trial research across the world. As in other aspects of life, the virus has severely affected the ability to conduct trials in safe...

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