compassionate use Archives - PharmaDeviceNews

GenSight Biologics begins LHON treatment under France compassionate access as REVISE Phase II moves forward

By Pallavi Madhiraju on March 21, 2026 Pharma & Biotech

GenSight Biologics begins treating ND4-LHON patients under France’s AAC compassionate access program. Analyse what REVISE and AAC mean for the regulatory pathway.

How Mitria Medical’s nitinol spacer challenges the edge-to-edge repair model for functional mitral regurgitation

By Pallavi Madhiraju on March 6, 2026 Medical Devices & Diagnostics

Mitria Medical’s Subvalvular Spacer reaches the U.S. under FDA compassionate use. What it means for FMR patients and what clinical evidence still needs to come.

What GenSight Biologics’ French CUA decision means for LHON gene therapy

By Pallavi Madhiraju on December 22, 2025 Pharma & Biotech

France grants compassionate use access to GenSight Biologics’ LUMEVOQ for LHON. Explore what this decision changes and what risks remain.