The once-monthly RNA interference injection medication received FDA approval based on results from the phase II PHYOX2 clinical trial and phase III PHYOX3 extension study.
The US Food and Drug Administration has approved the drug based on the results from the KEEPsAKE-1 and KEEPsAKE-2 randomized, placebo-controlled studies.
A new therapeutic agent added to standard of care significantly improves outcomes for patients with serious complication of systemic lupus erythematosus.
After 2 randomized clinical trials found it as safe and effective as the standard 3-drug regimen, the FDA approved the first 2-drug regimen for adults with HIV-1 who have never been treated with ART.
After a clinical trial demonstrated its efficacy, the FDA approved a new treatment option for adult and pediatric patients with a rare, inherited metabolic disorder.
The US Food and Drug Administration recently approved the first pill with an embedded digital ingestion tracking system for patients with schizophrenia, bipolar disorder, and depression.
After clinical trials demonstrated its safety and efficacy, the US Food and Drug Administration approved Simponi Aria for 2 new indications in adult patients.
