FDA Assigns PDUFA Date for Donepezil Transdermal System
Adlarity is a once-weekly transdermal formulation of donepezil.
Neurologic Disorders
Gantenerumab Designated Breakthrough Therapy for Alzheimer Disease
The FDA has granted Breakthrough Therapy designation to gantenerumab, an anti-amyloid beta antibody, for the treatment of Alzheimer disease.
Eisai Begins Rolling BLA Submission of Lecanemab for Early Alzheimer Disease
Lecanemab is an investigational anti-amyloid beta protofibril antibody.
Briviact Approval Expanded to Include Younger Patients with Partial-Onset Seizures
Briviact is now indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
Trial Evaluating Ravulizumab for Amyotrophic Lateral Sclerosis Discontinued
Following a prespecified interim analysis, the decision to halt the study was made based on the recommendation from the Independent Data Monitoring Committee.
Oral Myosin Inhibitor Fast Tracked for Becker Muscular Dystrophy
EDG-5506 is a selective, small molecule myosin inhibitor designed to protect injury-susceptible fast skeletal muscle fibers.
Complaint Prompts FDA Action on Use of Purple Patient Bracelets, Wristbands
The alert comes after a recent complaint about a purple wristband with a different meaning.
Evidence to Support Suicidality Warning for Newer Antiseizure Meds Lacking
The analysis included 5 antiseizure medications (eslicarbazepine, perampanel, brivaracetam, cannabidiol, and cenobamate) evaluated in 17 randomized clinical trials.
Hyperuricemia, Gout Do Not Raise Dementia Risk
Hyperuricemia and gout may be associated with a lower risk for Alzheimer disease.
Botox Approval Expanded to Include 8 New Muscles for Upper Limb Spasticity
The indication for adult upper limb spasticity treatment now includes elbow and forearm muscles, intrinsic hand muscles, and thumb muscles.
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