The US FDA has revoked the Emergency Use Authorization (EUA) for Cue Health’s two Covid-19 tests and has classified the ...

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 ...

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 ...

On October 7, 2024, FDA granted marketing authorization for the over‑the‑counter combination flu and COVID-19 combination test, Healgen Rapid ...

Regulating drug discovery and pharmaceutical manufacturing, the FDA ensures the safety and effectiveness of innovative ...

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 ...

Kennedy Jr., who is slated to hold a potentially big role in a new Trump administration, said Wednesday there are “entire departments” within the Food and Drug Administration (FDA) that ...

Oct 16 (Reuters) - The U.S. Food and Drug Administration has put on hold a trial of Novavax's (NVAX.O), opens new tab COVID-influenza and its standalone flu vaccines after a participant who took ...

Preliminary Q3 2024 PEMGARDA™ (pemivibart) net product revenue of $9.3 million; Invivyd ended Q3 2024 with approximately $107 million in cash and ...