BioSpace1d
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 ...
GlobalData on MSN1d
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 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 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 ...
Hosted on MSN3h
Hologic Wins Key Approvals Post Q1 Results: Buy or Hold HOLX Stock?
Hologic HOLX earned two key regulatory approvals. The company’s Affirm Contrast Biopsy software has earned the CE Mark, having previously been cleared by the FDA in October 2020. Meanwhile, the Aptima ...
Health Affairs6d
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 ...
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 ...
philstar.com11h
PNP defends EDSA bus lane use over ‘emergency,’ but DILG clarifies no authorization
PNP Chief General Rommel Marbil defended a police convoy flagged for using the EDSA busway, saying it was responding to an ...
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 ...