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.
General Neurology
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).
FDA Approves DBS Neurostimulation System With Brain Signal Tracking
The FDA has approved the Percept™ PC Deep Brain Stimulation (DBS) system (Medtronic) with BrainSense™ technology for neurological disorders.
Uplizna Approved for Neuromyelitis Optica Spectrum Disorder
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.
Gocovri sNDA Under Review for Off Episodes in Parkinson Disease
The FDA has accepted for review the supplemental New Drug Application (sNDA) for Gocovri® (amantadine extended-release; Adamas Pharmaceuticals) for the treatment of off episodes in Parkinson disease (PD) patients receiving levodopa-based therapy.
