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

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

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

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

“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 ...

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The US Food and Drug Administration (FDA ... marketing authorization outside of an emergency use authorization (EUA). Similar OTC flu/COVID-19 tests are currently available only under an EUA.

(Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the European Commission granted Marketing Authorization for Novavax's updated ...

The U.S. FDA granted marketing authorization for Healgen Scientific LLC’s Rapid Check COVID-19/Flu A&B antigen test.

The ads “violate the spirit of the EUA, if not the letter of the law.” The ad blitz was plastered across television and social media and later celebrated by drug industry insiders as one of the most ...