Siemens Healthineers announces that the U.S. Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for the CLINITEST Rapid COVID-19 Antigen Self-Test,1, 2, 3 providing nationwide access to a new at-home or over-the-counter self-test as COVID-19 testing needs.

Scientists at Scripps Research, University of Chicago and Icahn School of Medicine at Mount Sinai have identified a new Achilles’ heel of influenza virus, making progress in the quest for a universal flu vaccine.

Scientists have identified unique “indicators” in the blood of patients with severe and fatal COVID, paving the way for simple diagnostic tests to help doctors identify who will go on to become critically ill.

Pfizer announced on Dec. 13, 2021 that it had entered into a definitive agreement to acquire Arena Pharmaceuticals, a clinical stage company specializing in therapies treating immuno-inflammatory diseases, for $6.7 billion dollars.

The US Food and Drug Administration said on Wednesday that it will consider Emergency Use Authorization submissions for SARS-CoV-2 variant genotyping assays.

The US Food and Drug Administration released a notice on Thursday that Meridian Biosciences' Revogene SARS-CoV-2 test is unlikely to be able to detect the Omicron variant.

UK molecular diagnostics company Genedrive said on Wednesday that its rapid molecular COVID-19 test has received CE marking.

FDA has granted another set of regulatory privileges under its breakthrough devices program. The latest batch is led by breakthrough designations for treatments of lung cancer and bone metastases that are in development at RefleXion Medical and Zetagen Therapeutics.

The US Food and Drug Administration said on Friday that it has updated its website tracking the potential impact of SARS-CoV-2 variants on molecular diagnostic tests to include tests likely affected by the Omicron variant.

The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for an at-home sample collection kit for SARS-CoV-2 molecular testing developed by nonprofit digital health firm Audere.