Currently, many so-called ‘laboratory developed tests,’ analyzed at many high-tech labs, face no FDA oversight

Findings seen in the year following policy changes

The warning comes following the death of a preterm infant who was administered a probiotic formulated with live bacterium.

Odronextamab is an investigational CD20xCD3 bispecific antibody.

Pombiliti must be administered in combination with Opfolda.

Model achieved balanced accuracy of 64.2 percent in internal validation, 63.7 percent in external validation.

Consistent benefits seen for White and Asian populations and consistent lack of benefits seen in Black populations.

UCMyRx exposure negatively linked to HbA1c but not to systolic BP among Hispanic patients with type 2 diabetes.

Entyvio for SC use is expected to be available by the end of October 2023.

Sotatercept is an investigational activin signaling inhibitor.