FDA Approves Nayzilam Nasal Spray to Treat Seizure Clusters
The Food and Drug Administration (FDA) has approved Nayzilam (midazolam) nasal spray for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity.
All articles by Diana Ernst, RPh
Xeomin Approved as First-Line Treatment for Blepharospasm
The FDA has approved Xeomin (incobotulinumtoxinA; Merz) as a first-line treatment for blepharospasm in adults.
Ruzurgi Approved for Pediatric Patients With Lambert-Eaton Myasthenic Syndrome
The Food and Drug Administration (FDA) has approved Ruzurgi (amifampridine; Jacobus Pharmaceutical) for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to <17 years of age.
Suvorexant Evaluated for Insomnia in Patients With Alzheimer Disease Dementia
A study evaluating the safety and efficacy of suvorexant for the treatment of insomnia in patients with mild to moderate Alzheimer disease dementia was presented at AAN 2019.
FDA: Boxed Warning, Contraindication Added to Several Insomnia Medications
A new Boxed Warning will be required in the prescribing information for several insomnia medications following reports of serious injuries and deaths associated with complex sleep behaviors where patients engaged in activities while not fully awake.
Fremanezumab Cluster Headache Development Program Discontinued
Teva announced that the ENFORCE phase 3 program for fremanezumab in the treatment of cluster headaches will be discontinued following results from a futility analysis.
Eptinezumab Biologics License Application Accepted by the FDA for Review
The FDA has accepted for review the Biologics License Application for eptinezumab (Alder BioPharmaceuticals), an investigational CGRP inhibitor for migraine prevention.
FDA Allows Marketing of First Medical Device for Treatment of ADHD
The FDA has permitted for marketing the first medical device indicated for the treatment of attention deficit hyperactivity disorder ADHD.
New Tool Alerts Public to Unlawfully Marketed Dietary Supplement Ingredients
In an effort to better alert the public of unlawful ingredients in dietary supplements, the FDA has created the Dietary Supplement Ingredient Advisory List, a new reference tool for consumers and manufacturers.
Short-Course Oral Treatment Option Approved for Relapsing Forms of MS
EMD Serono announced that the Food and Drug Administration (FDA) has approved Mavenclad (cladribine) tablets for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (SPMS).
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