Latest News - Product Launches and Updates

Tuesday, November 07, 2017

Oral Vimpat Approved for Use in Pediatric Patients with Partial-Onset Seizures

The FDA approved a label extension for Vimpat (lacosamide, UCB) CV as an oral option for the treatment of partial-onset seizures (POS) in pediatric patients four years and older. The expanded ind…

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Thursday, October 19, 2017

Phenogenetic Database For Stem Cell Models of Neurological Diseases Launched

Based on the results of a novel meta-analysis of all induced pluripotent stem cells, researchers have created an atlas of how cell characteristic in neurological and neurodegenerative diseases are lin…

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Monday, October 09, 2017

Next-Generation VNS System and Implantable Device Approved

LivaNova has received FDA approval for its next-generation Vagus Nerve Stimulation (VNS) Therapy Programming System for drug-resistant epilepsy. The FDA has also approved the company's SenTiv…

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Wednesday, October 04, 2017

FDA Greenlights Two Generic Glatiramer Acetate Formulations for Relapsing MS

The FDA approved Mylan’s generic versions of glatiramer acetate, including a three-times weekly 40mg/mL formulation of glatiramer acetate and a once-daily 20mg/mL formulation…

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Wednesday, September 20, 2017

FDA Approves Intellis Device for Intractable Pain

The FDA has approved the Intellis platform (Medtronic) for the management of certain types of chronic intractable pain. The Intellis platform was designed to overcome limitations with current spinal c…

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Friday, September 15, 2017

Briviact Approved as Monotherapy for Partial-Onset Seizures

The FDA has approved a supplemental new drug application for Briviact (brivaracetam, UCB) CV as monotherapy for partial-onset (focal) seizures (POS) in patients 16 years and older with epile…

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Thursday, September 14, 2017

Aptiom Approved for Partial-Onset Seizures in Patients Four Years of Age and Older

The FDA has approved the supplemental New Drug Application (sNDA) to expand the indication for Aptiom (eslicarbazepine acetate, Sunovion) to include treatment of partial-onset seizures in childre…

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Wednesday, July 19, 2017

CSL Behring: FDA Accepts sBLA for Hizentra® for Chronic Inflammatory Demyelinating Polyneuropathy

The FDA has accepted for review CSL Behring’s supplemental Biologics License Application (BLA) for Hizentra®([Immune globulin subcutaneous [Human] 20% liquid) for the treatment for…

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Friday, June 30, 2017

VNS Therapy Approved in Children Ages Four Years and Older with Partial Onset Refractory Seizures

The FDA has approved the VNS Therapy (LivaNova) in patients as young as four years of age with partial onset refractory seizures. Originally approved for patients ages 12 years and older, VNS The…

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Tuesday, May 16, 2017

Endovascular Intervention Found Effective for "Late Window" Stroke Patients: DAWN Trial Analysis

The window for reducing disability and improving functional independence in stroke patients receiving endovascular therapy could extend as far as 24 hours, according to preliminary results from the DA…

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Thursday, May 04, 2017

MS Topography App Launches

A new app that offers a new, visual way of understanding multiple sclerosis (MS) was recently launched at the American Academy of Neurology Annual Meeting in Boston. The app is a disease simulation th…

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Wednesday, May 03, 2017

New Data Highlight Efficacy and Safety of Brain Responsive Neuromodulation for Reduction of Seizures

Two new studies offer long-term perspective on the efficacy and safety of brain responsive neuromodulation for the reduction of seizures. One study evaluated the effects of NeuroPace’s RNS Syste…

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Wednesday, April 12, 2017

First Treatment for Tardive Dyskinesia Approved in US

The FDA approved the selective VMAT2 inhibitor Ingrezza (valbenazine, Neurocrine Biosciences), making it the first treatment approved in the US to treat adults with tardive dyskinesia. The efficacy of…

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Wednesday, January 25, 2017

Memory Impairment Screening Tool Gains FDA Clearance

The FDA has granted 510(k) clearance to CANTAB Mobile (Cambridge Cognition), a sensitive screening tool for the detection clinically-relevant memory impairment in older adults at the point of care. CA…

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Thursday, January 19, 2017

Takeda and Ovid Strike Partnership to Develop Investigational Agent for Rare Pediatric Epilepsy

Takeda and Ovid Therapeutics are teaming up for the clinical development and commercialization of Takeda’s investigational new drug TAK-935, a novel CH24H inhibitor, in rare pediatric epilepsies…

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