Briumvi Now Available for Multiple Sclerosis Treatment
The CD20-directed cytolytic antibody therapy was approved based on data from two phase 3 trials.
The CD20-directed cytolytic antibody therapy was approved based on data from two phase 3 trials.
Donanemab is an antibody therapy that targets a modified form of deposited amyloid-β peptide called N3pG.
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.
AXS-05 is an investigational agent consisting of a proprietary formulation of dextromethorphan and bupropion.
SRP-9001 is an investigational gene transfer therapy designed to deliver a shortened, functional component of dystrophin to muscle tissue.
Efgartigimod is currently marketed under the trade name Vyvgart and is available as a single-dose vial for intravenous infusion after dilution.
Serdexmethylphenidate is a proprietary prodrug of d-methylphenidate.
The FDA has approved Sezaby (phenobarbital sodium powder for injection) for the treatment of neonatal seizures in term and preterm infants.
Gantenerumab is an investigational immunoglobulin G1 antibody designed to increase the clearance of soluble amyloid beta from the brain.
Zilucoplan is a subcutaneous, self-administered, macrocyclic peptide inhibitor of complement component 5.