Latest News - FDA Approval/Clearance

Tuesday, August 08, 2017 | FDA Approval/Clearance, Neuromuscular & Immune Disorders, Personnel/Company News

Recently Approved ALS Treatment Radicava Now Available

Radicava (edaravone, Mitsubishi Tanabe Pharma America), an intravenous therapy indicated for all adult patients diagnosed with amyotrophic lateral sclerosis (ALS), is now available for treatment in th…

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Tuesday, August 01, 2017 | FDA Approval/Clearance, Pain & Headache

Non-Invasive Neuromodulation Device for Chronic Intractable Pain Cleared by FDA

The FDA has cleared the Stimpod NMS460 (Xavant Technology), a non-invasive neuromodulation device for the symptomatic relief and management of chronic intractable pain. When applied to the affected ar…

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Friday, July 21, 2017 | FDA Approval/Clearance, Imaging & Testing

FDA Clears First MRI System for Neonatal Brain Imaging

The FDA cleared the Embrace Neonatal MRI System, the first of its of its king specifically for neonatal brain and head imaging in neonatal intensive care units (NICU). The Embrace Neonatal MRI System …

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Friday, May 05, 2017 | FDA Approval/Clearance, Neuromuscular & Immune Disorders, Phase 3/4 Trials, Research and Publications

FDA Greenlights First New Treatment for ALS in More than Two Decades

The FDA has approved Radicava (edaravone, MT Pharma), as an intravenous infusion treatment for amyotrophic lateral sclerosis (ALS). Radicava is the first treatment approved for the treatment of A…

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Tuesday, April 18, 2017 | FDA Approval/Clearance, Pain & Headache

FDA Releases Non-Invasive VNS Therapy for Pain Associated with Episodic Cluster Headache

The FDA has released the use of gammaCore, a non-invasive vagus nerve stimulator for the acute treatment of pain associated with episodic cluster headache in adult patients. gammaCore transmits a mild…

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Wednesday, April 12, 2017 | FDA Approval/Clearance, Movement Disorders, Product Launches and Updates

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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Tuesday, April 04, 2017 | FDA Approval/Clearance, Movement Disorders, Neuromuscular & Immune Disorders, Phase 3/4 Trials

New Therapy for Chorea Associated with Huntington’s Disease Wins FDA Approval

The FDA approved Austedo (deutetrabenazine, Teva Pharmaceuticals) tablets for the treatment of chorea associated with Huntington’s disease (HD), making it just the second product approved for th…

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Thursday, March 30, 2017 | FDA Approval/Clearance, Pain & Headache

FDA Approves Expanded Indication For Qudexy XR Extended Release Capsules

The FDA has approved two supplemental indications for Qudexy XR (topiramate, Upsher-Smith) Extended Release Capsules for use as prophylaxis of migraine headache in adults and adolescents 12 years of a…

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Tuesday, March 28, 2017 | Clinical Trials, FDA Approval/Clearance, Neuromuscular & Immune Disorders, Phase 3/4 Trials, Research and Publications, Genentech, Roche

Ocrevus Receives FDA Greenlight for Relapsing, Primary Progressive Forms of Multiple Sclerosis

The FDA has approved Ocrevus (ocrelizumab, Roche/Genentech) for the treatment of both relapsing and primary progressive forms of multiple sclerosis. Ocrelizumab is a humanized antibody that …

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Wednesday, March 22, 2017 | FDA Approval/Clearance, Movement Disorders

Novel Adjunct Agent Approved for Parkinson’s "Off" Periods

The FDA approved Xadago (safinamide, Newron Pharmaceuticals) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing &ld…

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Friday, February 10, 2017 | FDA Approval/Clearance, Neuromuscular & Immune Disorders

New Corticosteroid Approved for Duchenne Muscular Dystrophy

The FDA approved Emflaza (deflazacort) tablets and oral suspension to treat patients age five years and older with Duchenne muscular dystrophy (DMD). Emflaza is the first FDA approved corticosteroid t…

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Wednesday, January 25, 2017 | Dementia & Cognitive Disorders, FDA Approval/Clearance, Product Launches and Updates

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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Wednesday, December 21, 2016 | FDA Approval/Clearance, Neuromuscular & Immune Disorders, Genentech, Roche

FDA Extends Review of MS Agent Ocrevus to March 2017

The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application of Genentech’s investigational agent for the treatment of multiple sclero…

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Tuesday, November 15, 2016 | FDA Approval/Clearance, Pain & Headache

New MRI Labeling Approved for St. Jude Medical’s SCS System

The FDA has approved new labeling for full-body magnetic resonance imaging (MRI) for St. Jude Medical’s Proclaim Elite Spinal Cord Stimulation (SCS) System. The new labeling ensures patients in …

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Tuesday, November 01, 2016 | FDA Approval/Clearance, Product Launches and Updates

Portable Brain Monitoring Information System Gains FDA Clearance

A new portable ultrasound device designed for rapid triaging and monitoring of patients with brain disorders has been cleared by the FDA. The Lucid System uses Trans Cranial Doppler to non-invasively …

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