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

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

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

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

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

The FDA found one Covid test manufacturer altered their product after they'd gained government approval. Here's what to know ...

“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 ...

DON'T FALL FOR THESE NEW SCAMS!• FTC Blog About Latest Scams: <a href=" FDA Approved Tests: <a href=" Become a channel member ...

Despite uncertainty around who will sit in The White House in January and what ramifications they may bring, the industry’s ...

On September 10, experts across disciplines, from infectious disease clinicians to regulators to representatives from the pharmaceutical industry, convened at the inaugural ImmunOptimize workshop in ...

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 ...