First-of-its-Kind Deep Brain Stimulation Directional Lead Approved
The system works with Medtronic’s Percept™ PC Neurostimulator.
General Neurology
NeuroSphere Virtual Clinic Allows for Remote Neuromodulation Therapy Management
Using the programmer app, clinicians are able to remotely prescribe new treatment settings to the patient’s neuromodulation device via cloud and Bluetooth-based technology.
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.
New Drug Application for Apomorphine Infusion Pump Submitted for Review
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.
Enspryng, a Self-Administered Treatment for NMOSD, Gets FDA Approval
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 Approved for Multi-Patient Dosing
Gadavist® Imaging Bulk Package is supplied as 604.72mg/mL of gadobutrol in 30mL and 65mL multidose containers.
Aducanumab Gets Priority Review for Alzheimer Disease
The FDA has accepted for Priority Review the Biologics License Application for aducanumab (Biogen) for the treatment of Alzheimer disease.
App Approval Provides Flexibility for Patients Treated With Abbott’s Neuromodulation Devices
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.
New Drug Product: Uplizna
This slideshow shows drug information for Uplizna. Click here for the complete Uplizna monograph.
Aducanumab BLA for Alzheimer Disease Submitted for FDA Review
Biogen has submitted its Biologics License Application (BLA) to the Food and Drug Administration (FDA) for aducanumab as a treatment of Alzheimer disease (AD).
