FDA Approves Ingrezza for Huntington Disease Chorea
Nearly half of patients receiving Ingrezza saw a more than 40% reduction in Huntington disease chorea severity by the end of the treatment period.
Diagnosis & Disease Information
Anti-Amyloid-Beta Vaccine Candidate Fast Tracked for Alzheimer Disease
The designation was supported by initial interim safety and immunogenicity data from the phase 1b/2 ABATE trial.
Intradiscal Injection of Condoliase Looks Promising for Lumbar Herniation
SI-6603 is administered via a single, direct intradiscal injection.
Rexulti Approved for Agitation Associated With Dementia Due to Alzheimer Disease
Brexpiprazole is an atypical antipsychotic.
Donanemab Associated With Significant Clinical Benefit in Early Alzheimer Disease
Donanemab is an investigational antibody therapy that targets a modified form of deposited amyloid-β peptide called N3pG.
Qalsody Approved for SOD1 Amyotrophic Lateral Sclerosis
The FDA has approved Qalsody (tofersen) for the treatment of adults with ALS who have a mutation in the SOD1 gene.
Prescription Device Cleared for Patients With Drug-Resistant Restless Legs Syndrome
The NTX100 TOMAC System was previously granted the FDA’s Breakthrough Device designation.
One-Time Gene Therapy Fast Tracked for Duchenne Muscular Dystrophy
RGX-202 is an investigational one-time gene therapy designed to deliver a transgene for a novel microdystrophin.
FDA Panel Votes on Tofersen for SOD1 Amyotrophic Lateral Sclerosis
Tofersen is an investigational antisense medicine that reduces the synthesis of SOD1 protein production.
FDA Requests Device Info for Novel Parkinson Disease Infusion Therapy
ABBV-951 is a solution of levodopa and carbidopa prodrugs for continuous subcutaneous delivery.
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