Latest News - FDA Approval/Clearance

Tuesday, November 07, 2017 | Epilepsy & Seizure Disorders, FDA Approval/Clearance, Phase 3/4 Trials, Product Launches and Updates

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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Tuesday, October 24, 2017 | Dementia & Cognitive Disorders, FDA Approval/Clearance, Phase 3/4 Trials, Research and Publications

FDA Fast-Tracks Alzheon’s Anti-Amyloid Alzheimer’s Agent

The FDA has granted Fast Track designation to Alzheon, Inc.’s investigational anti-amyloid drug ALZ-801 for the treatment of Alzheimer’s disease (AD). Using a precision medicine approach, …

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Thursday, October 12, 2017 | FDA Approval/Clearance, Headache & Pain, Phase 3/4 Trials, Research and Publications, Pfizer

Once-Daily Lyrica Formulation Wins FDA Approval

The FDA has approved Lyrica CR (pregabalin, Pfizer) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and t…

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Monday, October 09, 2017 | Epilepsy & Seizure Disorders, FDA Approval/Clearance, Product Launches and Updates

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 Approval/Clearance, Multiple Sclerosis & Immune Disorders, Product Launches and Updates

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 Approval/Clearance, Headache & Pain, Product Launches and Updates

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 | Epilepsy & Seizure Disorders, FDA Approval/Clearance, Product Launches and Updates

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 | Epilepsy & Seizure Disorders, FDA Approval/Clearance, Product Launches and Updates

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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Thursday, August 31, 2017 | FDA Approval/Clearance, Movement Disorders

Austedo Approved for Treatment of Tardive Dyskinesia

The FDA has approved Austedo (deutetrabenazine, Teva Pharmaceutical Industries Ltd.) tablets for the treatment of tardive dyskinesia in adults. The approval was based on results from two Phase 3 …

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Friday, August 25, 2017 | FDA Approval/Clearance

Adamas: FDA Approves Gocovri for Dyskinesia

FDA has approved Adamas Pharmaceuticals, Inc.’s Gocovri (amantadine) extended release capsules (previously ADS-5102) for treatment of dyskinesia in patients with Parkinson's disease receivin…

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Tuesday, August 08, 2017 | FDA Approval/Clearance, Multiple Sclerosis & 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, Headache & Pain

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, Multiple Sclerosis & 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, Headache & Pain

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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