The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for baricitinib (Eli Lilly and Company) in combination with remdesivir for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal memb…
Hayes News
Hayes News Service keeps our clients up to date with late-breaking news from clinical trials, coverage decisions, and new product approvals. We focus on emerging technologies with potentially high clinical and financial impact as soon as they are announced publicly.
Our analysts scan more than 75 peer-reviewed journals and news briefings from government agencies, medical associations, and research institutes. Results of selected studies or articles are summarized and posted with a brief commentary on whether the findings are likely to have a substantial impact.
NIH COVID-19 Treatment Guidelines Panel Statement on Bamlanivimab
On November 18, 2020, the National Institutes of Health (NIH) issued a statement on the Food and Drug Administration (FDA) Emergency Use Authorization of bamlanivimab for the treatment of COVID-19.
FDA Authorizes First COVID-19 Test for Home Use
The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home.
FDA Safety Alert: Cook Medical Wire Guides
The Food and Drug Administration (FDA) is reporting on a recall of Cook Medical fixed core wire guides due to a manufacturing error.
FDA Safety Alert: Trevo XP ProVue Retriever
The Food and Drug Administration (FDA) has announced a recall of the Trevo XP ProVue Retriever (Stryker Neurovascular) due to a safety risk.
FDA Issues Emergency Use Authorization for Bamlanivimab for COVID-19
The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bamlanivimab (Eli Lilly and Company) for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.
COVID-19 Vaccine Candidate Achieved Success in First Interim Analysis
Pfizer Inc. and BioNTech SE have announced an interim analysis from a phase III trial of their COVID-19 vaccine candidate. Based on the first interim efficacy analysis, the mRNA-based vaccine candidate, BNT162b2, has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection.
FDA Safety Alert: Medtronic Rashkind Balloon Septostomy Catheters
Medtronic Inc. is recalling Rashkind Balloon Septostomy Catheters because of device quality issues that may lead to the device breaking, separating, or failing during use. If this occurs, use of the affected product may cause serious adverse health consequences, such as vascular injury and death.
FDA Update: NASA Ventilator Emergency Use Authorization
The FDA has added a ventilator developed by the National Aeronautics and Space Administration (NASA) to the COVID-19 ventilator emergency use authorization (EUA).