The Food and Drug Administration (FDA) has issued a communication to health care providers regarding the risk of nontuberculous mycobacteria (NTM) infections in patients who have undergone cardiothoracic surgery using heater-cooler devices.
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 Food and Drug Administration (FDA) has approved Nucala (mepolizumab; GlaxoSmithKline) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease.
The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for an antibody point-of-care (POC) test for COVID-19.
The American Academy of Pediatrics (AAP) has released interim guidance for return to sports after COVID-19 infection.
The Food and Drug Administration (FDA) is reporting on recalls of several models of Alaris System Infusion Pumps (BD/CareFusion 303).
The Food and Drug Administration (FDA) has issued an alert regarding a clinical trial studying the use of atezolizumab (Tecentriq; Genentech Inc.) and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC).
The Food and Drug Administration (FDA) has approved Gavreto (pralsetinib; Blueprint Medicines) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC)
The Food and Drug Administration (FDA) is reporting on Mylan N.V.’s voluntary nationwide recall of specific lots of amiodarone HCl injection and tranexamic acid injection due to the potential of the cartons being mislabeled.
Last week, the Food and Drug Administration (FDA) broadened the scope of the existing emergency use authorization (EUA) for Veklury (remdesivir; Gilead Sciences Inc.).
The Food and Drug Administration (FDA) has announced a Class I recall of certain Smiths Medical Syringe Pumps due to a risk of medication delivery errors.