FDA News

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.

A phase 1b and Phase 2 study are up next for the novel potential MDD treatment.

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.

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