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 Approves Inqovi for Myelodysplastic Syndromes

    On July 7, 2020, the Food and Drug Administration (FDA) approved a new drug application for Inqovi (decitabine and cedazuridine; Astex Pharmaceuticals Inc.) for treatment of adult patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).

    FDA News Briefs

    The Food and Drug Administration (FDA) recently announced these newly approved therapeutic agents.

    FDA Approves Fintepla for Dravet Syndrome

    On June 26, 2020, the Food and Drug Administration (FDA) approved a new drug application (NDA) for Fintepla (fenfluramine; Zogenix Inc.), an oral selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.

    NIH Halts COVID-19 Hydroxychloroquine Trial

    The National Institutes of Health (NIH) announced on June 20, 2020, that the ORCHID study evaluating the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with COVID-19 has been stopped.

    FDA Approves New Treatment for Neuromyelitis Optica Spectrum Disorder

    On June 11, 2020, the Food and Drug Administration (FDA) approved a biologics license application (BLA) for Uplizna (inebilizumab-cdon; Viela Bio) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.