FDA actions in brief, March 2009 (Gelnique, RiaSTAP, Kapidex)

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.

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.

Opdivo Qvantig is the first subcutaneously administered PD-1 inhibitor approved by the FDA. It is expected to be available in early January 2025 and will be priced at parity to the IV version of Opdivo.