FDA News

In an open letter to the public, Lilly decries use of tirzepatide products Mounjaro and Zepbound for nonmedical purposes and warns of counterfeit formulations.

If approved the 21-valent shot would be the first pneumococcal conjugate vaccine indicated specifically for adults.

The US FDA approved expanded indications for bempedoic acid and bempedoic acid plus ezetimibe for primary hyperlipidemia.

Crinecerfont was granted FDA breakthrough therapy designation for the treatment of congenital adrenal hyperplasia.

Camouflaging e-cigarettes as kid- and teen-appealing drinks and toys may help youth conceal the products from adults, increase risk of harm to children.

The second GLP-1 mimetic-based drug approved for chronic weight management, tirzepatide may outperform semaglutide, the first.

The novel potassium-competitive acid blocker is the first new treatment approved for the potentially cancer-producing GI disease in 30 years.

The Pfizer product is the first vaccine indicated to prevent the 5 most common serogroups causing meningococcal disease in adolescents and young adults.

The FDA cites insufficient evidence to show the products would be beneficial for adults switching to vaping from combustible tobacco products or quitting.

The Novavax COVID-19 vaccine is refreshed with 2023-2024 formula targeting the XBB.1.5 strain.