Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.

The approval was supported by pooled data from 2 open-label, single arm trials: the phase 2 NI-0501-06 study and the phase 3 EMERALD trial.

Bemarituzumab targets FGFR2b, which has been found to be overexpressed in approximately 30% of patients with non-HER2 positive gastric cancer.

The ACIP is a federal advisory committee composed of medical and public health experts who make recommendations on the use of vaccines for adults and children in the US.

Nonsignificant increase seen from 2023; 11.6% of adults aged 18 to 64 and 5.1%of children aged 0 to 17 were uninsured in 2024.

Total adverse events of heart failure or all-cause mortality were reduced with empagliflozin, regardless of kidney function.

This pull out will cost 100s of thousands of children’s lives a year, and RFK Jr. will be personally responsible,” said Atal Gawande.