Press Release: Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US

Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US Paris, April 22, 2026. The US Food and Drug Administration (FDA) has extended by up to three months the target action date for its review of the biologics license application for Sarclisa (isatuximab-irfc) subcutaneous (SC) in combination with approved standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all currently approved US indications of Sarclisa intravenous (IV) formulation.