Press Releases
Geneius Develops Off-the-Shelf T Cell Therapy Targeting SARS-CoV-2
Geneius Biotechnology is developing T cells as a quasi-personalized, off-the-shelf, therapy and preventive measure against COVID-19. The assumption is that by increasing the number of antigen-specific T cells in the body, the patient’s immune system can overwhelm the SARS-CoV-2...
News
Gilead’s drug remdesivir gets US FDA’s emergency use authorisation for COVID-19
Gilead was granted EUA by U.S. FDA for the investigational antiviral remdesivir to treat COVID-19. The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease, enabling access to remdesivir at additional hospitals across...
Press Releases
Hardy Diagnostics announces FDA EUA for antibody test and increases manufacturing capacity for COVID-19 products
Hardy Diagnostics, a medical device manufacturer based in Santa Maria, California, announced FDA EUA approval on April 24th for a new in vitro diagnostic medical device: Anti-SARS-CoV-2 Rapid Test (Cat. No. RTA0203).
This immunoassay is intended for qualitative detection and...
Clinical Trials
A World Pharma Today exclusive with Jim Murphy, CEO, Greenphire
Who would have thought a pandemic in this modern era would cripple the world, the strongest economies would be shaken, and end up being so vulnerable despite having the most modern technologies and processes at our disposal. That being...
Press Releases
BioLab Sciences to Distribute Rapid Antibody Test for COVID-19
BioLab Sciences, a regenerative biotechnology company, announced they are now distributing tests to detect antibodies specific to 2019n-CoV in humans. The test devices complete the screening using a blood sample from a finger prick and produce results in 10...
Press Releases
Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in as Little as Five Minutes
Abbott announced that the U.S. FDA has issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in...
Articles
Start “Early” in Healthy for timely results for your dosage form
Early phase bioequivalence studies are/can be conducted on all USFDA Orange book approved list of dosage forms based on submission requirements by pharmaceutical companies This has been a market trend for more than 2 decades.
USFDA Orange book lists nearly...
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