Showing 1871-1880 of 2192 results for "".
- FDA Clears Brain–Computer Interface Device for the Measurement and Stimulation of Cortical Brain Activityhttps://practicalneurology.com/news/fda-clears-braincomputer-interface-device-for-the-measurement-and-stimulation-of-cortical-brain-activity/2474229/The Food and Drug Administration (FDA) has granted 510(k) clearance to the Layer 7 Cortical Interface device (Precision Neuroscience, New York Ci
- Substantially Higher Mortality Risk Demonstrated for Children and Adolescents with Severe Epilepsy and Sleep Apneahttps://practicalneurology.com/news/substantially-higher-mortality-risk-demonstrated-for-children-and-adolescents-with-severe-epilepsy-and-sleep-apnea/2474009/Study results presented at the American Academy of Neurology (AAN) 2025 Annual Meeting demonstrate that central sleep apnea (CSA) and other sleep apnea, including obstructive sleep apnea (OSA), are associated with an increased risk of mortality in children and adolescents aged 1 to 17 years with
- Norepinephrine Reuptake Inhibitor Treatment Significantly Reduced Cataplexy Attacks in People with Narcolepsy Type 1https://practicalneurology.com/news/nri-therapy-significantly-reduced-cataplexy-attacks-in-people-with-narcolepsy-type-1/2473965/Treatment with AXS-12 (reboxetine; Axsome, New York, NY), a highly selective norepinephrine reuptake inhibitor (NRI) and cortical dopamine modulator, was associated with significant reductions in cataplexy attacks in people with narcolepsy type 1 (NT1), according to results from the phase 3 SYMPH
- The FDA Approves a Once-Daily Medication for Treating Hyperphagia Caused by Prader-Willi Syndromehttps://practicalneurology.com/news/the-fda-approves-a-once-daily-medication-for-treating-hyperphagia-caused-by-prader-willi-syndrome/2473822/The Food and Drug Administration (FDA) has approved Vykat XR (diazoxide choline [DCCR] extended-release tablets; Soleno, Redwood City, CA) for the treatment of hyperphagia in people with Prader-Willi syndrome (PWS) aged 4 years and older. Vykat XR is an extended-release formulation of DCCR, a cry
- Soliris Now Approved to Treat Children with Generalized Myasthenia Gravishttps://practicalneurology.com/news/soliris-now-approved-to-treat-children-with-generalized-myasthenia-gravis/2473804/The Food and Drug Administration (FDA) has approved the expansion of the indication of Soliris (eculizumab; Alexion Pharmaceuticals, Boston, MA) to now include treatment for pediatric patients aged ≥6 years with anti-acetylcholine receptor (AChR) antibody positive generalized myasthenia gravis
- FDA Approves Tenecteplase Treatment for Acute Ischemic Strokehttps://practicalneurology.com/news/fda-approves-tenecteplase-treatment-for-acute-ischemic-stroke/2473803/TNKase (Tenecteplase; Genentech, South San Francisco, CA) has received approval from the Food and Drug Administration (FDA) for the treatment of adults with acute ischemic stroke. TNKase is a tissue plasminogen activator, thrombolytic agent that is administered as a single 5-second intravenous (I
- Radiprodil Designated a Breakthrough Therapy for GRIN-Related Neurodevelopmental Disorderhttps://practicalneurology.com/news/radiprodil-designated-a-breakthrough-therapy-for-grin-related-neurodevelopmental-disorder/2473793/Radiprodil (GRIN Therapeutics, New York, NY), a selective, potent negative allosteric modulator of the N-methyl-D-aspartate receptor subtype SB (NR2B or GluN2B), has been granted Breakthrough Therapy designation by the Food and Drug Administration (FDA) for the treatment of seizures associated wi
- New Tablet Formulation of Evrysdi for Spinal Muscular Atrophy Greenlighted by the FDAhttps://practicalneurology.com/news/new-tablet-formulation-of-evrysdi-for-spinal-muscular-atrophy-greenlighted-by-the-fda/2473784/A New Drug Application (NDA) for a tablet formulation of Evrysdi (risdiplam; Genentech, South San Francisco, CA) has been approved by the Food and Drug Administration (FDA) for the treatment of participants aged ≥2 years with spinal muscular atrophy (SMA) who weigh ≥20 kg. Evrysdi was first
- Continuous, Subcutaneous Apomorphine Infusion Device Approved for Parkinson’shttps://practicalneurology.com/news/continuous-subcutaneous-apomorphine-infusion-device-approved-for-parkinsons/2473778/The Food and Drug Administration (FDA) has approved the wearable Onapgo (apomorphine hydrochloride; Supernus Pharmaceuticals, Rockville, MD) subcutaneous injection device to treat motor fluctuations in adults with advanced Parkinson disease (PD). Onapgo enables continuous apomorphine infusion dur
- Anaphylaxis Boxed Warning Added to MS Medication Labelhttps://practicalneurology.com/news/anaphylaxis-boxed-warning-added-to-ms-medication-label/2473770/The Food and Drug Administration (FDA) has added a Boxed Warning to the prescribing information of glatiramer acetate, a medication for multiple sclerosis (MS) sold under the brand name Copaxone (glatiramer acetate injection; Teva, Tel Aviv-Yafo, Israel) and the generic name Glatopa (glatiramer a