FDA COVID-19 Alert: Beware of Misleading Registration Certificates
How to tell if a device is approved, cleared, or authorized by the FDA During the COVID-19 pandemic, some companies are selling medical devices (including […]
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FDA Approves TEPMETKO® as the First and Only Once-daily Oral MET Inhibitor
….for Patients with Metastatic NSCLC with METex14 Skipping Alterations Merck today announced that the US Food and Drug Administration (FDA) has approved TEPMETKO® (tepotinib) following […]
Roche receives FDA Emergency Use Authorization for new test to measure the level of SARS-CoV-2 antibodies
• 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 and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine
—————————————————————————————————————- 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) […]
Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients
• Immunocompromised transplant patients are at risk of major complications when infected with BK virus • cobas BKV test addresses critical need for hospitals and […]
Roche receives FDA Emergency Use Authorization for the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems
• 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 […]
Novartis Cosentyx® receives FDA approval for new indication to treat active non-radiographic axial spondyloarthritis
• 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 […]
FDA: Certain COVID-19 Serology/Antibody Tests Should Not Be Used
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- Outbreak Investigation of Listeria monocytogenes: Enoki Mushrooms
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 […]
Roche’s Elecsys IL-6 test receives FDA Emergency Use Authorisation
….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 […]
FDA approves olaparib for HRR gene-mutated metastatic castration-resistant prostate cancer
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 […]
FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high PD-L1 expression
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 […]