Showing 1531-1540 of 1692 results for "".
- 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
- FDA Clears Intranasal Foralumab for Clinical Investigation as a Potential Treatment for Alzheimer Diseasehttps://practicalneurology.com/news/fda-clears-intranasal-foralumab-for-clinical-investigation-as-a-potential-treatment-for-alzheimer-disease/2470269/Tiziana Life Sciences’ (New York, NY) investigational new drug (IND) application for intranasal foralumab has been cleared by the Food and Drug Administration (FDA), authorizing further investigations into the agent&r
- FDA Approves Film Formulation of Migraine Drughttps://practicalneurology.com/news/fda-approves-film-formulation-of-migraine-drug/2470157/The Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for a film formulation of rizatriptan benzoate (Rizafilm VersaFilm; IntelGenx Corp, Saint-Laurent, Quebec, Canada) for the treatment of acute
- Dry Powder Formulation of Dihydroergotamine Adheres to Nasal Lining and Safely Treats Migrainehttps://practicalneurology.com/news/dry-powder-formulation-of-dihydroergotamine-adheres-to-nasal-lining-and-safely-treats-migraine/2469937/In the ASCEND (NCT04406649) safety and tolerability study, a novel dry powder formulation of dihydroergotamine (DHE) (STS101; Satsuma Pharmaceuticals, South San Francisco, CA) was found safe and tolerable for use as an acute treatment