Freenome won FDA approval for its SimpleScreen blood-based colorectal cancer test, a step designed to bring AI-enhanced cfDNA methylation screening into routine care. The company said Abbott will exclusively commercialize the test in the U.S. starting this fall, and that SimpleScreen meets Medicare coverage criteria. On the therapy side, Otsuka’s Simtriyo (centanafadine) cleared FDA approval as a once-daily extended-release capsule for ADHD in adults and pediatric patients age 6 and older, with specified weight criteria. Otsuka framed the approval as an expansion of its norepinephrine–dopamine–serotonin reuptake inhibition mechanism in a population with limited options that require sustained exposure. Together, the moves highlight two tracks of momentum: AI-driven screening tools expanding outside traditional stool-based workflows, and extended-release neuropsychiatry dosing moving toward broader label coverage.