USPSTF recommendations on estrogen and progesterone; semaglutide assessed in obese teenagers; efficacy and safety data released for investigational maternal RSV vaccine; updates to Clozapine REMS; FDA panel votes on investigational CNS/leptomeningeal metastasis treatment.
Omburtamab is an investigational radiolabeled monoclonal antibody designed to target tumor cells that express B7-H3.
Alymsys is a vascular endothelial growth factor inhibitor.
Vegzelma is a vascular endothelial growth factor inhibitor.
DSP-0390 is an inhibitor of emopamil-binding protein, an endoplasmic reticulum membrane protein involved in cholesterol biosynthesis.
The accelerated approval was based on data from two phase 2 trials: the ROAR basket study and the NCI-MATCH Subprotocol H study.
VBI-1901 is an investigational bivalent eVLP vaccine immunotherapeutic candidate designed to target 2 highly immunogenic CMV antigens, gB and pp65.
Omburtamab is an investigational radiolabeled monoclonal antibody designed to target tumor cells that express B7-H3.
The approval was based on data demonstrating that the biosimilar product and the reference product were highly similar, and that there were no clinically meaningful differences between the agents.
The application could not be approved in its present form due to manufacturing deficiencies.
