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

    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.

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    FDA Approves New Indication for Nucala

    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.

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    FDA Recall Alert

    The Food and Drug Administration (FDA) is reporting on recalls of several models of Alaris System Infusion Pumps (BD/CareFusion 303).

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    FDA Alert for mTNBC Drug Combination

    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).

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    FDA Approves New NSCLC Treatment

    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)

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    Recall Alert: Amiodarone and Tranexamic Acid

    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.

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