Chester County News and Community Website
EXTON, PA — Megna Health announced that its Rapid COVID-19 IgM/IgG Test, previously authorized for use under the U.S. Food and Drug Administration (FDA) Emergency Use Authorization, is now available …
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WASHINGTON, D.C. — The U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the …
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WASHINGTON, D.C. — The U.S. Food and Drug Administration announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine. The first revision clarifies the …
Read MoreWASHINGTON, 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 …
Read More 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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MALVERN, PA — ADVAITE’s RapCov™ Rapid COVID-19 Test, one of the first US manufactured FDA EUA authorized point-of-care (PoC) serology tests, is now available via Amazon Business.
Read MoreWASHINGTON, D.C. — The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is a …
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WASHINGTON, D.C. — The U.S. Food and Drug Administration issued an emergency use authorization (EUA) this week for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals …
Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration this week issued guidance for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential …
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WASHINGTON, D.C. — The U.S. Food and Drug Administration has issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in …
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