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 Recall Alert

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

    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).

    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)

    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.

    FDA Broadens Veklury EUA

    Last week, the Food and Drug Administration (FDA) broadened the scope of the existing emergency use authorization (EUA) for Veklury (remdesivir; Gilead Sciences Inc.).

    FDA Approves Enspryng for NMOSD

    The Food and Drug Administration (FDA) has approved Enspryng (satralizumab-mwge; Genentech Inc.) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults.

    FDA Approves Viltepso for DMD

    On August 12, 2020, the Food and Drug Administration (FDA) granted accelerated approval to Viltepso (viltolarsen; NS Pharma Inc.) injection for the treatment of Duchenne muscular dystrophy (DMD).