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Top Medical News
Risdiplam Gets Priority Review for Presymptomatic SMA in Babies Under 2 Months
January 25, 2022
By Abby Reinhard
The submission to the FDA is supported by interim data from the RAINBOWFISH trial (NCT03779334), as all 5 babies treated with risdiplam maintained the ability to swallow and feed exclusively orally after 12 months.
Actigraphy Identified as a Valid Tool for Sleep Assessment in Children With Cerebral Palsy
January 25, 2022
By Abby Reinhard
Investigators developed a weighted logistic regression-based sleep-wake scoring method for actigraphy data, concluding that it aided in assessing sleep in CP.
Phase 2 Trial of Sodium Oligomannate in Parkinson Disease Greenlit by FDA
January 25, 2022
By Marco Meglio
Approximately 300 patients across 30 clinical centers will be included in the 36-week study evaluating the efficacy and safety of sodium oligomannate (GV-971), a medication currently approved for Alzheimer disease in China.
Nerivio Shows Effectiveness as Acute Migraine Treatment in Large-Scale, Real-World Analyses
January 25, 2022
By Marco Meglio
Device-related adverse events were reported in less than 1% of the safety analysis population, which included more than 100,000 patients with migraine who were treated with Nerivio.
Application Accepted for Oral Edaravone in Amyotrophic Lateral Sclerosis
January 24, 2022
By Abby Reinhard
The FDA accepted the new drug application for priority review, setting a PDUFA action date of May 12, 2022.
