• Elecsys® Anti-SARS-CoV-2 S test specifically detects antibodies against the SARS-CoV-2 spike protein • The spike protein is the target of many COVID-19 vaccines in […]
—————————————————————————————————————- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will submit a request today to the U.S. Food and Drug Administration (FDA) […]
• Immunocompromised transplant patients are at risk of major complications when infected with BK virus • cobas BKV test addresses critical need for hospitals and […]
• First commercial test for fully automated high throughput systems to detect and differentiate SARS-CoV-2, influenza A virus and/or influenza B virus with a single […]
• FDA approval for Cosentyx® is based on the Phase III PREVENT trial, demonstrating efficacy in active non-radiographic axial spondyloarthritis (nr-axSpA), which is part of […]
Letter to Clinical Laboratory Staff and Health Care Providers The U.S. Food and Drug Administration (FDA) recommends that clinical laboratories and health care providers stop […]
FDA’s investigation is complete. CDC declares outbreak over. The FDA, along with CDC and state and local partners investigated a multistate outbreak of Listeria monocytogenes […]
….to help in identifying patients at high risk of severe inflammatory response • FDA EUA1 now makes IL-6 testing accessible to patients in the United […]
On May 19, 2020, the Food and Drug Administration approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals, LP) for adult patients with deleterious or suspected deleterious germline or […]
Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors […]
The U.S. Food and Drug Administration (FDA) has published a new directory of email addresses for medical device questions during the COVID-19 pandemic. This directory […]
On May 15, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) as […]
Copyright © 2021 | WordPress Theme by MH Themes