Following two 12-week studies, the FDA has approved the first ever medication for treating agitation in patients with dementia due to Alzheimer disease.
The FDA has approved a treatment for Friedreich ataxia after the results of randomized, placebo-controlled study indicate a strong effectiveness in treatment.
The FDA has approved a drug therapy to treat seizures associated with Dravet syndrome–a chronic, rare, and life-threatening form of epilepsy–among patients aged 2 years or older.
The FDA has granted a landmark approval to an intravenous injection for the imaging of tau pathology among patients with cognitive impairment being evaluated for Alzheimer disease.
This approval comes after the drug was found to be safe and effective in 2 randomized, double-blind, placebo-controlled trials including 655 adults with partial-onset seizures.
After a clinical trial showed the treatment was more effective than placebo, the FDA approved the first treatment for episodic cluster headache in adults that reduces the frequency of attacks.
