This week, news of the FDA’s vote on AMX0035, the novel ALS treatment; CPAP and BiPAP device recalls; Orphan Drug designation for a novel CRISPR therapy; Imfinzi gains new approval; and Spevigo is approved for pustular psoriasis flares.
According to the FDA, the magnets from the mask can “potentially affect the functioning of or cause movement of certain implanted metallic medical devices.”
Stay up-to-date on the latest drugs in development.
The designation is supported by data from the phase 2 MARIPOSA study, which included adults with mild to moderate OSA.
The Agency issued the notification order as it deemed the Company’s notification efforts to be inadequate.
Findings seen in secondary analysis of data for children randomly assigned to adenotonsillectomy or watchful waiting for nonsevere OSA
About 2 million of the recalled machines were in use in the United States
Meta-analysis shows sleep apnea linked to increased risk for sudden death, cardiovascular mortality
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.
