FDA has accepted Teva’s ecopipam NDA with Priority Review after Phase 3 treatment reduced the risk of tic relapse by 53% among pediatric responders.
LUCIDITY met its FDA-agreed primary endpoint with a 55% lower composite rate of Level 2 and Level 3 hypoglycemic events, supporting an NDA planned by year-end.
FDA approval gives adults with fibrodysplasia ossificans progressiva another treatment option after OPTIMA recorded just one to two new bone lesions with Pasatru versus 19 with placebo over 56 weeks.
FDA accelerated approval makes Genglycos the first treatment for GSDIa, based on a 31% reduction in daily cornstarch intake that must now be confirmed through long-term follow-up.
Cortechs.ai’s NeuroQuant PET can automatically quantify amyloid PET uptake, generate SUVR and Centiloid measurements and send structured results into imaging workflows.
A peer-reviewed NSCLC study found mature tertiary lymphoid structures in 47% of Aliya PEF-treated tumors versus 24% of controls, an exploratory signal that now needs clinical validation.
ImpediMed’s new FDA clearance adds sarcopenia risk assessment to the SOZO platform, potentially allowing muscle-loss monitoring alongside existing fluid and body-composition measurements.
Hyperfine’s newest FDA-cleared Optive AI software adds isotropic T1 imaging, stronger noise correction and workflow changes to its portable ultra-low-field Swoop MRI system.
C2N Diagnostics’ FDA-cleared PrecivityAD2 combines amyloid and tau measurements in a mass-spectrometry test intended to aid assessment of symptomatic adults aged 40 and older.
Empatica can now bring PKG-derived Parkinson’s measures into its wearable ecosystem after FDA clearance of a platform designed for continuous symptom monitoring.