FDA Alerts

The FDA approved ustekinumab-auub as an interchangeable biosimilar with ustekinumab for multiple inflammatory diseases.

In late September, the FDA approved the first biosimilar to tocilizumab to treat adult and pediatric patients with various indications of arthritis.

The FDA has approved the first biosimilar treatment for patients living with relapsing forms of multiple sclerosis.

Tirzepatide is now approved for a new indication. The dual GIP/GLP-1 agonist was previously approved for treating type 2 diabetes in May 2022.

The FDA approved the use of quizartinib for certain patient populations with acute myeloid leukemia in July 2023.

Following two randomized studies, the FDA has approved zuranolone for the treatment of postpartum depression in adults—the first if its kind.

The FDA approved the second over-the-counter nasal spray with the goal of increasing access to products that can rapidly reverse the effects of opioid overdose.

The FDA approved the new round of vaccines for those 12 years and older and authorized emergency use for children 6 months to 11 years of age.

The FDA approval follows a single-arm, multicenter, open-label trial in 91 patients with uveal melanoma with unresectable hepatic metastases.

Following a multicenter clinical trial, a new treatment for pneumonia caused by Acinetobacter baumannii-calcoaceticus has been approved for use in adults.