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.
The new antibacterial drug was approved after it was proven safe and effective in a study of 448 patients with complicated UTIs.
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.
The US Food and Drug Administration has approved a quadrivalent option for the prevention of influenza in adults aged 65 years and older.
The Food and Drug Administration has approved a new option for the treatment of acute, uncomplicated influenza in patients aged 12 years and older who are at high risk for developing flu-related complications.
The FDA has approved a new option for HIV-1 pre-exposure prophylaxis to reduce HIV-1 infection risk from sex, excluding in those who have receptive vaginal sex.
The FDA has approved a type 2 diabetes medication for the reduction of risk of end-stage kidney disease and cardiovascular events in adults with type 2 diabetes and diabetic kidney disease.
The FDA has approved a new option for the treatment of granulomatosis with polyangiitis and microscopic polyangiitis in children aged 2 years and older.
The FDA has expanded the approval a new option for the treatment of adults and children aged 12 years and older or weighing at least 99 pounds with chronic hepatitis C virus genotypes 1, 2, 3, 4, 5, or 6 infection and compensated cirrhosis who are treatment-naïve.
The FDA has approved Jynneos, a new live, non-replicating vaccination for the prevention of smallpox and monkeypox in adults aged 18 years and older who are at high risk for the diseases.