Novel Therapy for Progressive Supranuclear Palsy Gets Orphan Drug Designation
The FDA has granted Orphan Drug designation to RT001 (Retrotope) for the treatment of progressive supranuclear palsy (PSP).
All articles by Brian Park, PharmD
FDA Accepts NDA for Diazepam Buccal Film for Management of Seizure Clusters
The Food and Drug Administration (FDA) has accepted for review the New Drug Application for Libervant® (diazepam; Aquestive Therapeutics) buccal film for the management of seizure clusters.
Investigational Therapy for Hypoxic-Ischemic Encephalopathy Gets Orphan Drug Status
The Food and Drug Administration (FDA) has granted Orphan Drug designation to PIC1-dPEG24 (ReAlta Life Sciences) for the treatment of hypoxic-ischemic encephalopathy (HIE) in neonates.
SUNFISH: Motor Function Improvement With Risdiplam in Type 2 or 3 Spinal Muscular Atrophy
Risdiplam is an investigational, orally administered liquid survival motor neuron-2 (SMN2) splicing modifier designed to increase and sustain SMN protein levels throughout the central nervous system and peripheral tissues of the body.
Suvorexant Labeling Updated to Include Data on Insomnia in Alzheimer Disease
The Food and Drug Administration (FDA) has approved updates to the prescribing information for Belsomra® (suvorexant; Merck) to include study findings for the treatment of insomnia in patients with mild to moderate Alzheimer disease.
FDA to Review Donepezil Transdermal System for Alzheimer Disease
A PDUFA target date of June 30, 2020 has been assigned to the application.
Video Game Based Digital Therapy Looks Promising in Pediatric ADHD Trial
Akili Interactive announced topline data from an open-label study (STARS-ADHD Adjunctive) of AKL-T01 for the treatment of attention deficit hyperactivity disorder in children with or without use of stimulants.
Lamotrigine Recalled Due to Cross-Contamination With Hypertension Medication
Taro Pharmaceuticals announced the voluntary recall of 1 lot of lamotrigine 100mg tablets to the consumer level due to cross-contamination with a small amount of enalapril maleate.
Lemborexant Approved for Insomnia Characterized by Difficulties With Sleep Onset, Maintenance
The FDA has approved lemborexant for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adult patients.
Ubrogepant Approved for Acute Treatment of Migraine
The Food and Drug Administration (FDA) has approved Ubrelvy (ubrogepant tablets; Allergan), the first oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine with or without aura in adults.
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