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The U.S. FDA has approved the expanded use of Organon's TOFIDENCE, a biosimilar to Roche's Actemra, to treat life-threatening immune reactions. The new indications include Cytokine Release Syndrome (CRS) in cancer patients and hospitalized COVID-19 patients, including pediatric cases, who require breathing support. These approvals, issued between June 10 and June 13, allow the drug to be used for a broader range of critical care and inflammatory conditions.