The Food and Drug Administration (FDA) has approved Cabenuva (cabotegravir and rilpivirine, injectable formulation; ViiV Healthcare) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history o…
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.
The FDA is alerting clinical laboratory staff and health care providers that genetic variants of SARS-CoV-2 may lead to false negative results with molecular tests for SARS-CoV-2.
The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has issued an interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine.
The Food and Drug Administration (FDA) has announced a recall of specific lots of sildenafil (AvKARE LLC) and trazodone (AvKARE LLC) tablets due to a product mix-up.
The Food and Drug Administration (FDA) has announced a recall of specific Baxter Healthcare software-controlled infusion pumps.
The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressi…
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…
The World Health Organization (WHO) has issued a conditional recommendation against the use of remdesivir in hospitalized patients, regardless of disease severity, citing a lack of evidence that remdesivir improves survival and other outcomes in these patients.
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.
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.