FDA grants EUA to Aptitude’s Covid/flu multiplex test for OTC use
In partnership with Sekisui Diagnostics, the company and its distribution partners have made the test available across the US ...
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FDA Shoots Down Invivyd’s Bid to Expand EUA for COVID-19 Antibody
Pemgarda has a standing emergency use authorization as a prophylaxis for immunocompromised patients, but FDA’s stringent ...
Biotech Alert: Searches spiking for these stocks today
These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They ...
Invivyd news ‘disappointing’ but not in model, says H.C. Wainwright
H.C. Wainwright maintains a Buy rating on Invivyd (IVVD) with a $10 price target after the FDA rejected its submission to expand Pemgarda’s ...
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Aptitude Receives FDA Authorization for Metrix® COVID/Flu Multiplex Molecular Test for Point-of-Care and Over-the-Counter Use
Aptitude Medical Systems, Inc. (Aptitude) today announced it has received Emergency Use Authorization (EUA) from the U.S.
FDA Rejects Invivyd's Request To Expand Emergency Authorization For Preventive COVID-19 Antibody For Immunocompromised Patients
Invivyd's bid to expand Pemgarda's EUA for COVID-19 treatment was denied by the FDA. The company will share new data on ...