FDA to Review Once-Nightly Sodium Oxybate Formulation for Narcolepsy
The NDA submission is supported by data from the phase 3 REST-ON study.
The NDA submission is supported by data from the phase 3 REST-ON study.
In patients with moderate to severe chronic rhinosinusitis with nasal polyposis, treatment with an Exhalation Delivery System With Fluticasone (EDS-FLU) is associated with improved sleep scores.
Treatment with omalizumab was associated with sleep improvements in patients with chronic rhinosinusitis with nasal polyps.
This week we cover a caution about remdesivir; New and updated Emergency Use Authorizations; And new approvals in sleep apnea and for Botox.
The eXciteOSA device is used while the individual is awake and provides electrical muscle stimulation through a mouthpiece that sits around the tongue.
This week the FDA and the WHO have a back and forth over remdesivir; Who should get a COVID vaccine; Xolair and Hetlioz have approval expansions; And a novel neuroblastoma treatment gets accelerated approval.
The approval was based on data from a 9-week, double-blind, placebo-controlled, crossover study which assessed the effects of Hetlioz in patients with SMS.
NightWare is a smartwatch application that uses the Apple Watch and Apple iPhone platform.
While valerian is considered a popular herbal supplement for managing sleep disorders, study outcomes related to its effectiveness have been inconsistent.
The approval was based on data from two phase 3 trials (HARMONY CTP and HARMONY 1) that evaluated the efficacy and safety of pitolisant for the treatment of cataplexy.