The target action date for Rexulti in combination with sertraline to treat patients with post-traumatic stress disorder, originally planned for Feb. 8, 2025, will be delayed.
Deramiocel is a cell therapy that has healing effects in muscle cells. If approved, deramiocel would be a once-quarterly therapy and the first specifically approved for cardiomyopathy in patients with Duchenne muscular dystrophy.
FDA officials have set a review date of June 30, 2025, to review avutometinib in combination with defactinib to treat patients with recurrent low-grade serous ovarian cancer.
In November 2024, a regulatory advisory board said the benefits of Zynquista does not outweigh the risks in adults with type 1 diabetes and chronic kidney disease.