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.

Together with Crossject's upcoming U.S. bioequivalence study, the manufactured batches and the new registration batches ...

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

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

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

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 ...

A copy of the posters and presentation will be available on the company’s website following the conference.

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 ...

As expected, the FDA has moved quickly to grant emergency use authorisation (EUA) to two new-generation COVID-19 mRNA vaccines from Pfizer/BioNTech and Moderna, both targeting the new Omicron ...