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FDA revokes EUA for Cue Health’s Covid-19 tests tagging recall as Class IIThe US FDA has revoked the Emergency Use Authorization (EUA) for Cue Health’s two Covid-19 tests and has classified the ...
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Thursday, the FDA granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include ...
The Pfizer/BioNTech bivalent COVID-19 vaccine (Original and Omicron BA.4/BA.5) has the FDA’s EUA for use in individuals 5 years and over as a single booster dose administered at least two months ...
A submission to the US Food and Drug Administration (FDA) requesting an Emergency Use Authorization (EUA) of a 10-µg booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for ...
Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart,” the FDA document went on. “Based on results from the clinical trial ...
PEMGARDA injection (4500 mg), for intravenous use is an investigational mAb that has not been approved, but has been authorized for emergency use by the U.S. FDA under an EUA for the pre-exposure ...
The FDA has cleared the Healgen Rapid Check COVID ... marketing authorization outside of an emergency use authorization (EUA). Similar OTC flu/COVID-19 tests are currently available only under ...
Invivyd reports clinical efficacy data from CANOPY phase 3 trial of pemivibart: Waltham, Massachusetts Friday, November 15, 2024, 18:00 Hrs [IST] Invivyd, Inc, a biopharmaceutical ...
While shopping for KN95 masks, experts recommend keeping the following factors in mind: These KN95 masks were featured on the FDA’s EUA list. They come in a pack of 40, are built with an ...
On October 7, 2024, FDA granted marketing authorization for the over‑the‑counter combination flu and COVID-19 combination test, Healgen Rapid ...
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