FDA News

Your daily dose of the clinical news you may have missed.

Specifically, the topical analgesics, available over the counter, may contain higher than labeled concentrations of lidocaine, according to the agency.

The FDA approved the oral medication to treat anemia in adult patients with chronic kidney disease on dialysis for at least 3 months.

For the first time, 2 drugs recommended as first line treatment for PAH are combined in a single oral once-daily therapy, which could reduced burden of care.

Bempedoic acid is now the only non-statin therapy indicated for primary CVD prevention, with potential to expand treatment access to millions, said Esperion Therapeutics.

Michael A. Weber, MD, an investigator in the PRECISION study, discusses the newly FDA approved drug aprocitentan (Tryvio), and its promise for helping patients with treatment-resistant hypertension.

The label expansion for semaglutide, based on the SELECT trial, includes data showing reduced risk of CV death of 15% and of death from any cause of 19%.

The surprise request for review of the phase 3 TRAILBLAZER-ALZ-2 clinical trial findings will delay the original PDUFA timing beyond first quarter 2024.

The Dexcom system is for adults over the age of 18 years who do not use insulin, such as individuals with T2D who use oral medications, a US population of 25 million.

Biosimilars Wyost and Jubobonti were approved as interchangeable for Xgeva and Prolia but launch will depend on the outcome of litigation between reference product manufacturers.