BioSpace19h
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 ...
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 ...
Invivyd, Inc.: FDA Declined Invivyd's Request to Expand Existing Emergency Use Authorization of PEMGARDA (pemivibart)
FDA's reasoning appears to center on a belief that COVID-19 treatment immunobridging analyses for a monoclonal antibody (mAb) must meet a standard of superior antiviral activity rather than equivalent ...
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. Food and Drug Administration (FDA) for its next-gen molecular Metrix® ...
Invivyd says FDA declines request to expand existing EUA of PEMGARDA
Invivyd (IVVD) announced that Invivyd’s request to expand the existing emergency use authorization for pre-exposure prophylaxis of COVID-19 EUA ...
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 ...
Invivyd Shares Down as Regulators Decline Expanded Use for Covid-19 Treatment
The commercial-stage biopharmaceutical company said its request to expand the existing emergency use authorization of the drug, also called pemivibart, to treat mild-to-moderate Covid-19 in more ...
Health Affairs5d
Demographic Variation In US Outpatient Hydroxychloroquine And Ivermectin Use During The COVID-19 Pandemic
As COVID-19 surged across the US starting in 2020, so too did the use of repurposed medications such as hydroxychloroquine and ivermectin to treat COVID-19 infections. Use of these medications ...
Business Wire13h
Seraph 100 Blood Filtration Media May Reduce Tumor-Associated Particles in Blood Samples Drawn From Pancreatic Cancer Patients
A new laboratory study has provided insights into the potential therapeutic benefits of blood purification for patients with metastatic pancreatic duc ...
Invivyd shares drop as FDA declines company's COVID-19 treatment EUA expansion
Monday said that its request to expand the existing emergency use authorization of PEMGARDA (pemivibart) to include treatment of mild-to-moderate COVID-19 for immunocompromised persons who have no ...
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 ...