FDA Clears Hand-Held Vagus Nerve Stimulator for Migraine Prevention
The FDA has approved an expanded indication for the gammaCore device to include prevention of migraine.
All articles by Brian Park, PharmD
Epidiolex Gets Priority Review for Tuberous Sclerosis Complex-Associated Seizures
The FDA has accepted for Priority Review the supplemental New Drug Application for Epidiolex.
Significant Reduction in Monthly Migraine Days Observed With Rimegepant in Prevention Trial
Biohaven announced positive topline results from a pivotal phase 2/3 study evaluating rimegepant for the preventive treatment of episodic and chronic migraine in adults.
Prescription Digital Therapeutic for Chronic Insomnia Gains FDA Approval
The FDA has approved Somryst™ (Pear Therapeutics), a prescription digital therapeutic (PDT) intended for the treatment of patients 22 years of age and older with chronic insomnia.
Lower Sodium Oxybate Formulation Gets Priority Review for Narcolepsy
The FDA has accepted for Priority Review the New Drug Application for JZP-258 for the treatment of cataplexy or excessive daytime sleepiness in patients aged ≥7 years with narcolepsy.
Gene Therapy for Frontotemporal Dementia With a GRN Mutation Gets Fast Track Status
The FDA has granted Fast Track designation to PR006 (Prevail Therapeutics), an experimental gene therapy, to slow the progression of frontotemporal dementia with a GRN mutation.
New Data Show Continued Benefit With Onasemnogene Abeparvovec-xioi in Spinal Muscular Atrophy
Patients with spinal muscular atrophy treated with a one-time infusion of onasemnogene abeparvovec-xioi continue to show clinically meaningful benefits even 5 years after dosing.
Verdiperstat Fast-Tracked for Multiple System Atrophy
The Food and Drug Administration has granted Fast Track designation to verdiperstat (BVH-3241; Biohaven) for the treatment of multiple system atrophy.
Rimegepant Orally Disintegrating Tablet Now Available for Acute Treatment of Migraine
Biohaven announced that rimegepant is now available for the acute treatment of migraine with or without aura in adults.
Epilepsy Therapy Cenobamate Designated Schedule V Controlled Substance
The DEA has designated Xcopri (cenobamate; SK Life Science) as a schedule V controlled substance, indicating a lower potential for abuse.
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