BioSpace10h
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 ...
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 ...
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 ...
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 ...
Business Wire5h
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 ...
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 ...
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 ...
Dr. Brittany Kizer Stovall Connects With Patients After Finding A Family And Her Medical Home Team
Brittany Kizer Stovall joined the first class of 53 students at University of South Carolina School of Medicine Greenville.