Showing 1081-1090 of 1148 results for "".
- FDA Grants Fast Track Designation to Autologous Investigational Cell Therapy for Parkinson Diseasehttps://practicalneurology.com/news/fda-grants-fast-track-designation-to-autologous-investigational-cell-therapy-for-parkinson-disease/2470319/ANPD001 (Aspen Neuroscience, San Diego, CA), a personalized, autologous investigational cell therapy product, has been granted Fast Track designation by the Food and Drug Administration (FDA) for investigation as a potential treatment for Parkinson disease (PD). ANPD001 is intended to replace los
- FDA Updates Nuplazid Label to Clarify Medication’s Indicationhttps://practicalneurology.com/news/fda-updates-nuplazid-label-to-clarify-medications-indication/2470299/The Food and Drug Administration (FDA) has updated the label for Nuplazid (pimavanserin; Acadia Pharmaceuticals, San Diego, CA) with revisions to the boxed warning and clinical studies sections for this atypical antipsychotic. The changes are intended to clarify that Nuplazid is used to treat peo
- 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
- Indirect Treatment Comparison Between Ingrezza and Austedo to Treat Chorea Associated with Huntington Diseasehttps://practicalneurology.com/news/indirect-treatment-comparison-between-ingrezza-and-autesto-to-treat-chorea-associated-with-huntington-disease/2470278/Ingrezza (valbenazine; Neurocrine Biosciences, San Diego, CA) may provide more benefit in early treatment of chorea symptoms associated with Huntington disease (HD) than Austedo (deutetrabenazine; Teva Pharmaceuticals, Tel Aviv, Israel), according to results of a study presented at the 2023 Inter
- Ingrezza Approved for the Treatment of Chorea Associated with Huntington Diseasehttps://practicalneurology.com/news/ingrezza-approved-for-the-treatment-of-chorea-associated-with-huntington-disease/2470271/Ingrezza (valbenazine; Neurocrine Biosciences, San Diego, CA) has received approval from the Food and Drug Administration (FDA) for the treatment of adults with chorea associated with Huntington disease (HD). The agent, del
- FDA Grants Orphan Drug Designation to Exon 44 Skipping AOC for Duchenne Muscular Dystrophyhttps://practicalneurology.com/news/fda-grants-orphan-drug-designation-to-exon-44-skipping-aoc-for-duchenne-muscular-dystrophy/2470270/AOC 1044 (Avidity Biosciences, San Diego, CA), an antibody oligonucleotide conjugate (AOC), was granted orphan drug designation by the Food and Drug Administration (FDA) for the treatment of patients with Duchenne muscular
- Full Results from LAVENDER Study Confirm Benefits of Daybue to Treat Rett Syndrome Symptomshttps://practicalneurology.com/news/full-results-from-lavender-study-confirm-benefits-of-daybue-to-treat-rett-syndrome-symptoms/2470208/According to new results of the LAVENDER study published in Nature Medicine, Daybue (trofinetide, Acadia Pharmaceuticals Inc., San Diego, CA) may be effective in treating and improving core symptoms of Rett syndrome
- FDA Grants Fast Track Designation for Antibody Oligonucleotide Conjugate to Treat Duchenne Muscular Dystrophyhttps://practicalneurology.com/news/fda-grants-fast-track-designation-for-antibody-oligonucleotide-conjugate-to-treat-duchenne-muscular-dystrophy/2470170/AOC 1044 (Avidity Biosciences, Inc, San Diego, CA), a drug in the new class of RNA therapeutics called antibody oligonucleotide conjugates (AOCs), was granted Fast Track designation by the Food and Drug Administration (FDA)
- New Therapy Approved for Rett Syndromehttps://practicalneurology.com/news/new-therapy-approved-for-rett-syndrome/2470139/The Food and Drug Administration (FDA) has approved trofinetide (Daybue; Acadia Pharmaceuticals, San Diego, CA) for the treatment of
- Pimavanserin Lowers Mortality Risk in Those with Parkinson Disease Psychosishttps://practicalneurology.com/news/pimavanserin-lowers-mortality-risk-in-those-with-parkinson-disease-psychosis/2470091/Results from a retrospective analysis published in Drug Safety indicate that individuals with Parkinson disease psychosis (PDP) treated with pimavanserin (Nuplazid; Acadia Pharmaceuticals, San Diego, CA) have a lower mortality risk compared with those treated with other atypical an