Organon wins FDA nod to expand TOFIDENCE use in severe CRS & COVID-19
- Posted on June 12, 2026
- By Bing News
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Organon wins FDA nod to expand TOFIDENCE use in severe CRS & COVID-19
Organon & Co. OGN recently announced that the FDA has approved a supplemental Biologics License Application (sBLA) for TOFIDENCE (tocilizumab-bavi), expanding the drug’s indications to include severe or life-threatening cytokine release syndrome (CRS) and certain hospitalized COVID-19 patients. TOFIDENCE is a biosimilar to ACTEMRA (tocilizumab) and was the first approved tocilizumab biosimilar in the United States. Per management, the expanded...
