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.
After clinical trials demonstrated its safety and efficacy, the US Food and Drug Administration approved a new option for adult patients with tardive dyskinesia.
The FDA is requiring boxed warnings for opioid analgesics and prescription opioid cough products related to combined use of certain opioids with benzodiazepines.
