Briumvi Now Available for Multiple Sclerosis Treatment
The CD20-directed cytolytic antibody therapy was approved based on data from two phase 3 trials.
Diagnosis & Disease Information
Limited Drug Exposure Data Halt Accelerated Approval Attempt for Donanemab
Donanemab is an antibody therapy that targets a modified form of deposited amyloid-β peptide called N3pG.
Brexpiprazole Gets Priority Review for Agitation With Alzheimer Dementia
The sNDA is supported by data from two phase 3 studies that evaluated the efficacy and safety of brexpiprazole in patients with agitation associated with Alzheimer dementia.
Dextromethorphan-Bupropion Delays Relapse of Alzheimer Disease Agitation
AXS-05 is an investigational agent consisting of a proprietary formulation of dextromethorphan and bupropion.
Gene Therapy Gets Priority Review for Duchenne Muscular Dystrophy
SRP-9001 is an investigational gene transfer therapy designed to deliver a shortened, functional component of dystrophin to muscle tissue.
Efgartigimod SC Formulation Gets Priority Review for Myasthenia Gravis
Efgartigimod is currently marketed under the trade name Vyvgart and is available as a single-dose vial for intravenous infusion after dilution.
Serdexmethylphenidate Gets Orphan Drug Status for Idiopathic Hypersomnia
Serdexmethylphenidate is a proprietary prodrug of d-methylphenidate.
Sezaby Approved to Treat Seizures in Term and Preterm Infants
The FDA has approved Sezaby (phenobarbital sodium powder for injection) for the treatment of neonatal seizures in term and preterm infants.
Gantenerumab Fails to Meet Endpoints in Early Alzheimer Disease Trials
Gantenerumab is an investigational immunoglobulin G1 antibody designed to increase the clearance of soluble amyloid beta from the brain.
FDA to Review Zilucoplan for Generalized Myasthenia Gravis
Zilucoplan is a subcutaneous, self-administered, macrocyclic peptide inhibitor of complement component 5.
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