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Regeneron's Garetosmab Receives FDA Priority Review for Rare Bone Disorder FOP

Mar 02, 2026

The FDA has accepted Regeneron's Biologics License Application for garetosmab to treat fibrodysplasia ossificans progressiva, granting Priority Review with a target action date of August 2026. The application is supported by Phase 3 OPTIMA trial data.

FDA Grants Priority Review to Regeneron's Garetosmab for Rare Bone Disease FOP

Mar 02, 2026

The FDA has accepted Regeneron's biologics license application for garetosmab with priority review, targeting fibrodysplasia ossificans progressiva. A decision is expected by August 2026 based on Phase 3 trial data showing significant reductions in new bone lesions.