On July 7, 2021, the Food and Drug Administration (FDA) posted a modified label for Aduhelm (aducanumab; Biogen Inc.) clarifying the population in which treatment should be initiated.
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: Philips Respironics Ventilators, BiPAP, and CPAP Machines
On June 30, 2021, the Food and Drug Administration (FDA) announced a recall of certain Philips Respironics ventilators, BiPAP, and CPAP machines due to potential health risks. These devices are used to provide breathing assistance.
FDA Issues Emergency Use Authorization for Actemra to Treat COVID-19
On June 25, 2021, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Actemra (tocilizumab; Genentech Inc.) for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal m…
FDA Approves New Treatment for Alzheimer Disease
Today the Food and Drug Administration (FDA) approved a biologics license application (BLA) for Aduhelm (aducanumab; Biogen) for the treatment of Alzheimer disease.
FDA Safety Alert: Medtronic HVAD System
The Food and Drug Administration (FDA) is alerting health care providers that Medtronic has stopped the sale and distribution of the Heartware Ventricular Assist Device (HVAD) System.
FDA Safety Alert: HeartWare HVAD System
Medtronic is recalling the HeartWare HVAD System to provide updated Instructions for Use and Patient Manual due to safety issues.
FDA Safety Alert: Novo Nordisk Samples
The Food and Drug Administration (FDA) has announced a recall of Levemir, Tresiba, Fiasp, Novolog, and Xultophy Product Samples (Novo Nordisk) due to improper storage temperature conditions.
FDA Safety Alerts
These safety communications were recently posted by the Food and Drug Administration (FDA).
FDA Safety Alert: Medtronic HeartWare HVAD
The Food and Drug Administration (FDA) has announced a recall of specific lots of the Medtronic HeartWare HVAD battery cables, data cables, adapter cables, and controller 2.0 ports due to risk of wear and tear.
FDA Safety Alerts
These safety communications were recently posted by the Food and Drug Administration (FDA).