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

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

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.

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.

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

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.

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

The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.

A single dose of a synthetic, proprietary formulation of psilocybin (COMP360) was found to improve symptoms in patients with treatment-resistant ...

Yeztugo (lenacapavir) is an HIV-1 capsid inhibitor that is administered every 6 months after an initial dosing regimen.

Enflonsia is an extended half-life RSV fusion glycoprotein neutralizing monoclonal antibody that is designed to provide durable protection through 5 months.

Vizamyl is now additionally indicated for use in a selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information.