FDA News

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.

The addition of ileus as a potential adverse event associated with the GLP-1 mimetic is not the first required for the class by the regulator.

The US Food and Drug Administration granted BTD to pegozafermin for the treatment of patients with NASH.

Empagliflozin is approved to lower the risk of sustained decline in eGFR, end-stage kidney disease, CV death, and hospitalization in adults with CKD at risk of progression.

Resmetirom, a once-daily oral, thyroid hormone receptor (THR)-β selective agonist, targets key underlying NASH pathophysiology in the liver.