Immunotherapeutic Vaccine Candidate Fast Tracked for Alzheimer Disease
UB-311 is an immunotherapeutic vaccine candidate that targets toxic forms of aggregated amyloid beta in the brain.
Neurologic Disorders
Ultomiris Approved for Generalized Myasthenia Gravis
The approval was based on data from a phase 3 study that included 175 adults with generalized myasthenia gravis who were not previously treated with a complement inhibitor.
Subcutaneous Anti-Amyloid Beta Antibody Fast Tracked for Alzheimer Disease
In preclinical studies, PRX012 has been shown to bind to beta amyloid plaques and oligomers with high affinity.
AMPK Activator Gets Fast Track Status for X-Linked Adrenoleukodystrophy
PXL770 is a novel, first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator.
Reductions in Amyloid Beta Plaques, P-Tau Seen With Aducanumab Over 2 Years Later
The long-term extension phase of the phase 3 EMERGE and ENGAGE trials evaluated the efficacy and safety of aducanumab-avwa in adults aged 50 to 85 years with early Alzheimer disease.
Donepezil Transdermal Patch Approved for Alzheimer Disease
Adlarity is a once-weekly transdermal formulation of donepezil that is designed to be worn for 7 days with consistent adhesion.
FDA Sets Date for Decision on Pimavanserin for Alzheimer Disease Psychosis
Acadia Pharmaceuticals resubmitted the sNDA after addressing issues raised in a Complete Response Letter issued by the Agency.
FDA Clears Cionic Neural Sleeve for Patients With Mobility Issues
The Cionic Neural Sleeve is the first product to combine movement analysis and augmentation into a wearable garment.
Certain Immune Globulin Products Withdrawn Due to Higher Rate of Hypersensitivity Reactions
The IGIV and IGSC products were voluntarily withdrawn due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.
Supernus One Step Closer to Decision on Apomorphine Infusion Device
SPN-830 provides a continuous subcutaneous infusion of apomorphine through an infusion pump.
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