The Lumipulse G β-Amyloid Ratio (1-42/1-40) test is intended to be used as an aid in adults 55 years of age and older presenting with cognitive impairment who are being evaluated for Alzheimer disease and other causes of cognitive decline.
The approval was based on data from a phase 3 trial that assessed Qelbree in adults 18 to 65 years of age with ADHD.
UB-311 is an immunotherapeutic vaccine candidate that targets toxic forms of aggregated amyloid beta in the brain.
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.
In preclinical studies, PRX012 has been shown to bind to beta amyloid plaques and oligomers with high affinity.
The guidance aims to ensure that the data submitted to the Agency adequately represent the patients that will use the medical products.
The phase 3 REDWOOD study included patients aged 30 years and older with primary autonomic failures and symptomatic neurogenic orthostatic hypotension.
Elamipretide has been shown to improve frataxin levels in Friedreich ataxia patient-derived cells, and improve motor and cardiac function in an animal model of Friedreich ataxia.
SPN-830 provides a continuous subcutaneous infusion of apomorphine through an infusion pump.
Glycopyrrolate Oral Solution is supplied as 1mg/5mL in a 16oz bottle.
