FDA Actions in Brief

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.

Kerenida is currently approved to slow the progression of chronic kidney disease associated with type 2 diabetes.

Regulators say, however, the benefits of vaccination with Abrysvo and Arexvy in preventing respiratory syncytial virus continue to outweigh their risks.

Effective Jan. 1, 2025, Independence Blue Cross has begun excluding coverage for 18 months for therapies — but not cancer drugs — that have an accelerated approval based on a surrogate endpoint.

Gastric cancer, commonly known as stomach cancer, is the fifth most common cancer globally and the fifth leading cause of cancer-related deaths.

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.