The Food and Drug Administration (FDA) has announced a recall of all lots of Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology, also known as JET 7 Xtra Flex.
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.
FDA Safety Alert: Meitheal Issues Recall
The Food and Drug Administration (FDA) has announced a recall of 1 lot of cisatracurium besylate injection (Meitheal Pharmaceuticals Inc.) due to mislabeling.
Clearlake-Backed symplr to Acquire Phynd
SANTA MONICA, CA and HOUSTON, TX – January 25, 2021 —(PRNEWSWIRE)— symplr, a leading global healthcare governance, risk management, and compliance (“GRC”) software-as-a-service (“SaaS”) platform, backed by Clearlake Capital Group, L.P. (together with its affiliates,...
FDA Approves New Injectable Drug Regimen for Adults Living with HIV
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…
FDA Alert: Genetic Variants May Lead to False Negative COVID-19 Results
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.
CDC Issues Interim Recommendation for COVID-19 Vaccine
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.
FDA Safety Alert: AvKARE Issues Recall
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.
FDA Safety Alert: Baxter Healthcare Infusion Pumps
The Food and Drug Administration (FDA) has announced a recall of specific Baxter Healthcare software-controlled infusion pumps.
FDA Authorizes Drug Combination for Treatment of COVID-19
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…
WHO Recommends Against Use of Remdesivir in COVID-19
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.