The Food and Drug Administration (FDA) recently announced these newly approved therapeutic agents.
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.
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.
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.
These updates were recently posted by the Food and Drug Administration (FDA).
The chief investigators of the Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial have released a statement reporting that dexamethasone may reduce mortality in hospitalized COVID-19 patients.
The Food and Drug Administration (FDA) is notifying health care providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate for the treatment of COVID-19 is not recommended, as it may result in reduced antiviral activity of remdesivir.
On June 15, 2020, the Food and Drug Administration (FDA) announced the revocation of the Emergency Use Authorization (EUA) of chloroquine and hydroxychloroquine for the treatment of COVID-19.
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.
On June 9, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a guide detailing considerations for resuming in-person, non-emergent, non-COVID-19 health care.
On June 5, 2020, the World Health Organization (WHO) issued updated interim guidance on the use of masks in the context of COVID-19.