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.
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.
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.
In a unanimous vote, the US FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended the approval of a new indication for a triglyceride-lowering drug.
After performance data showed 95% sensitivity and specificity, the FDA authorized the assay’s marketing in the United States for detection of HIV-1 drug-resistant mutations.