FDA Clears Rapid Blood Test for Mild Traumatic Brain Injury
The test measures glial fibrillary acidic protein and ubiquitin carboxyl-terminal hydrolase L1, biomarkers present in blood plasma at elevated concentrations after a brain injury.
The test measures glial fibrillary acidic protein and ubiquitin carboxyl-terminal hydrolase L1, biomarkers present in blood plasma at elevated concentrations after a brain injury.
The NDA for SPN-830 is supported by data from an extensive development program that includes the phase 3 TOLEDO study and a supportive open-label study.
The FDA has approved Enspryng (satralizumab-mwge; Genentech) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Gadavist® Imaging Bulk Package is supplied as 604.72mg/mL of gadobutrol in 30mL and 65mL multidose containers.
The FDA has accepted for Priority Review the Biologics License Application for aducanumab (Biogen) for the treatment of Alzheimer disease.
The FDA has approved an iOS-compatible app designed to work in tandem with Abbott’s neuromodulation technologies. The Company hopes the app will eliminate the need for patients to carry a separate programmer device and improve remote care.
This slideshow shows drug information for Uplizna. Click here for the complete Uplizna monograph.
Biogen has submitted its Biologics License Application (BLA) to the Food and Drug Administration (FDA) for aducanumab as a treatment of Alzheimer disease (AD).
The FDA has approved the Percept™ PC Deep Brain Stimulation (DBS) system (Medtronic) with BrainSense™ technology for neurological disorders.
The FDA has approved UpliznaTM (inebilizumab-cdon; Viela Bio) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.