News | January 09, 2026
Oculis’ Privosegtor wins FDA breakthrough therapy status for Optic Neuritis
The FDA designation follows visual-function results from the Phase 2 ACUITY trial
The FDA designation follows visual-function results from the Phase 2 ACUITY trial
This is the first controlled pharmacologic study to demonstrate that treatment of obesity improved PsA disease measures
The trial aims to measure AF burden—the percentage of time patients spend in arrhythmia—as its primary efficacy endpoint
Receiving Orphan Drug Designation is an important milestone in the clinical development of CK0804 for myelofibrosis
The MAGiC catheter is designed for robotically-navigated cardiac ablation procedures
SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage
Heart failure affects an estimated 64.3 million people worldwide
The approval introduces a needle-free alternative to injectable GLP-1 therapies
The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation
CystoSmart, an AI tool designed to detect bladder tumors during screening and surveillance cystoscopy, is brand-agnostic and works with flexible, rigid, and single-use scopes
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