FDA News

The FDA has approved the first generic once-daily GLP-1 injection for the improvement of glycemic control for type 2 diabetes in patients 10 years and up.

The black box warning, the agency's most prominent alert, follows earlier additions to the original fezolinetant label about hepatic injury and regular LFT testing.

This marks the second indication for tirzepatide in just more than a year, following its November 2023 approval for adults with obesity or overweight and weight-related medical problems.

Nemolizumab is the first approved monoclonal antibody that targets IL-31 receptor alpha, inhibiting the signaling of IL-31, which drives disease mechanism in atopic dermatitis.

Intra-Cellular Therapies submitted an sNDA to the FDA for lumateperone for the treatment of MDD in adults as as adjunctive therapy to antidepressants.

The Prescription Drug User Fee Act date is set for May 7, 2025.

After a 3-year negotiation, the FDA has cleared a phase 2 clinical trial assessing the use of smoked cannabis for the treatment of PTSD symptoms in veterans.

Aprocitentan is the first-and-only dual endothelin receptor antagonist approved for the treatment of systemic hypertension.

The target action date for the FDA decision is April 18, 2025, according to Sanofi and Regeneron.

The FDA cleared Novavax to start enrolling the planned phase 3 trial after a safety concern was found to be unrelated to the combination vaccine.