Phase 3 COVER DFUS II trial data show the autologous therapy plus standard of care significantly improves wound closure rates at 12 weeks.

The application is supported by phase 2 APEX trial data, which demonstrated a 65% objective response rate among patients with advanced disease.

The sNDA approval provides clinicians with the first FDA-cleared photodynamic therapy for skin cancer, backed by phase 3 trial data demonstrating superior clinical and histologic clearance.

Progressive decrease in adjusted odds of hospitalization seen in association with vaccination versus no vaccination.

SAMA and SABA + SAMA use associated with increased risk for heart failure, arrhythmia, and mortality versus no use ...