The recall follows a warning letter sent by the US Food and Drug Administration (FDA) noting unauthorised changes to the ...

The campaign “caused Americans to lose trust in the public health system,” House Energy and Commerce Committee Chair Cathy ...

The FDA today issued a notice classifying the recall of Cue Health COVID-19 tests as Class II and revoking the tests' EUA.

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 ...

Product batch announced in July yielded new regulatory stability data. These results will directly support the requested 6-month stability data ...

The Houston-based firm is set to scale up its Flu/Covid test manufacturing for the current respiratory virus season.

“Our combo test addresses a critical gap in clinical diagnostic testing by providing a reliable and user-friendly solution for individuals to test themselves at home,” says Dr Bingliang Fang, CEO of ...

The FDA has determined that the monoclonal antibody pemivibart (Pemgarda) is likely to be effective against currently circulating SARS-CoV-2 variants, including KP.3.1.1 and LB.1. "Based on ...

Flooding of the Baxter manufacturing plant in North Carolina during Hurricane Helene prompted the FDA to declared a shortage ...

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 US FDA has revoked the Emergency Use Authorization (EUA) for Cue Health’s two Covid-19 tests and has classified the formerly voluntary recall of the two tests as Class II. The two tests in ...

Share on Facebook. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA has determined that the monoclonal antibody ...