Showing 1561-1570 of 1732 results for "".
- FDA Grants Clearance to OneRF Trigeminal Nerve Ablation System for Facial Painhttps://practicalneurology.com/news/fda-grants-clearance-to-onerf-trigeminal-nerve-ablation-system-for-facial-pain/2483016/The Food and Drug Administration (FDA) has granted 510(k) clearance to the OneRF Trigeminal Nerve Ablation System (NeuroOne Medical Technologies Corporation [NeuroOne], Eden Prairie, MN), authorizing its use for the treatment of pain or for lesioning nerve tissue during neurosurgical procedures t
- FDA Greenlights Phase 2a Trial of Intranasal Foralumab in Multiple System Atrophyhttps://practicalneurology.com/news/fda-greenlights-phase-2a-trial-of-intranasal-foralumab-in-multiple-system-atrophy/2476103/The Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application, permitting the evaluation of treatment with intranasal foralumab (Tiziana Life Sciences, New York, NY) for people with multiple system atrophy (MSA) in a phase 2a clinical trial (NCT06868628). MSA i
- Seizure Freedom During Pregnancy Strongly Predicts Postpartum Seizure Controlhttps://practicalneurology.com/news/seizure-freedom-during-pregnancy-strongly-predicts-postpartum-seizure-control/2474277/For people with epilepsy of childbearing potential (PWECP) seizure freedom during pregnancy was shown to be a strong predictor of seizure freedom in the postpartum period. This finding from an analysis of results of the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONE
- 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
- Intranasal Foralumab Receives Fast Track Designation as Potential Tx for Non-Active SPMShttps://practicalneurology.com/news/intranasal-foralumab-receives-fast-track-designation-as-potential-tx-for-non-active-spms/2470554/An intranasal formulation for foralumab (Tiziana Life Sciences, New York, NY) has been granted Fast Track Designation by the Food and Drug Administration (FDA) for investigation as a potential treatment for non-active Secondary Progressive Multiple Sclerosis (na-SPMS). Foralumab is a fully human
- FDA Approves Ingrezza Sprinkle Formulation for Tardive Dyskinesia or Chorea Associated with Huntington Diseasehttps://practicalneurology.com/news/fda-approves-ingrezza-sprinkle-formulation-for-tardive-dyskinesia-or-chorea-associated-with-huntington-disease/2470463/The Food and Drug Administration (FDA) has approved a new sprinkle formulation of Ingrezza (valbenazine; Neurocrine Biosciences, San Diego, CA) for patients with tardive dyskinesia (TD) or chorea associated with Huntington disease (HD). The oral granule capsules (available in 40 mg, 60 mg, and 80
- PrimeC Oral Formulation Shows Promise as a Potential Treatment Candidate for ALShttps://practicalneurology.com/news/primec-oral-formulation-shows-promise-as-a-potential-treatment-candidate-for-als/2470457/According to new secondary endpoint data reported from the PARADIGM clinical trial (NCT05357950), PrimeC (ciprofloxacin/celecoxib; NeuroSense Therapeutics, Cambridge, MA), a novel, extended-release oral formulation drug candidate that combines ciprofloxacin and celecoxib, was shown to be associat
- Prognostic Value of Serum NfL for Predicting Lesion Formation in MS Affirmed by ASCLEPIOS I/IIhttps://practicalneurology.com/news/prognostic-value-of-serum-nfl-for-predicting-lesion-formation-in-ms-affirmed-by-asclepios-iii/2470447/People with relapsing multiple sclerosis (RMS) who had higher 3- and 12-month on-treatment serum neurofilament light chain (sNfL) levels were found to have higher annualized rates of new or emerging T2 (neT2) lesion formation, according to findings from the phase 3 ASCLEPIOS I/II clinical trials
- Subcutaneous Leqembi Formulation Clears More Amyloid Plaque than IV Formulation According to Clarity AD OLEhttps://practicalneurology.com/news/subcutaneous-leqembi-formulation-clears-more-amyloid-plaque-than-iv-formulation-according-to-clarity-ad-ole/2470325/Weekly administration of a subcutaneous (SC) formulation of Leqembi (lecanemab-irmb; Eisai, Tokyo, Japan; Biogen, Cambridge, MA) showed 14% more amyloid plaque removal than biweekly intravenous (IV) Leqembi treatment, according to interim data from a preliminary analysis. The data analyzed was fr
- New Drug Application Accepted for Oral Granule Sprinkle Formulation of Ingrezzahttps://practicalneurology.com/news/new-drug-application-accepted-for-oral-granule-sprinkle-formulation-of-ingrezza/2470295/The Food and Drug Administration (FDA) accepted the new drug application (NDA) for Ingrezza (valbenazine; Neurocrine Biosciences, San Diego, CA) oral granules. This is a new sprinkle formulation of the once-daily capsule version of Ingrezza, which was approved previously to treat tardive dyskines