FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 Infection

WASHINGTON, D.C. — The U.S. Food and Drug Administration has issued an emergency use authorization (EUA) for the first machine learning-based Coronavirus Disease 2019 (COVID-19) non-diagnostic screening device that identifies …

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FDA

FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process

WASHINGTON, D.C. — The U.S. Food and Drug Administration recently granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification …

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Melior Pharmaceutical

Chester County-based Pharmaceutical Company Receives IND Clearance from FDA for COVID-19 Therapeutic

EXTON, PA — Melior Pharmaceuticals announced that it has received clearance of its Investigational New Drug (IND) application for the clinical development of its novel, first-in-class lyn kinase activator, tolimidone, …

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