Organon says FDA approves expanded TOFIDENCE use in CAR-T cytokine release syndrome

Organon & Co.

Organon & Co.

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  • FDA cleared expanded US uses for Organon’s TOFIDENCE (tocilizumab-bavi), adding CAR-T-induced severe or life-threatening cytokine release syndrome.
  • The label also now covers hospitalized COVID-19 patients aged 2+ on systemic steroids who need oxygen support, ventilation, or ECMO.
  • Organon acquired US regulatory and commercial rights to TOFIDENCE in 2025; Bio-Thera Solutions retains US manufacturing rights.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Organon & Co. published the original content used to generate this news brief via Business Wire (Ref. ID: 202606100730BIZWIRE_USPR_____20260610_BW519993) on June 10, 2026, and is solely responsible for the information contained therein.

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