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.
The FDA has released a warning about the potential for an increase in disability in patients with multiple sclerosis who stop taking this immunosuppressant.
The US Food and Drug Administration has granted approval to the first treatment in a new drug class for a nerve condition that affects about 50,000 people worldwide.
Following the success of 3 clinical trials, the US Food and Drug Administration granted approval to a once-monthly, self-injectable preventive treatment for adults with migraine.
Based on evidence from several clinical trials, an FDA advisory committee has voted unanimously to recommend the approval of a cannabis-based oral solution for the treatment of 2 rare forms of epilepsy. ...