FDA approves REMS-related supplement for Lynozyfic (linvoseltamab-gcpt)
The FDA cleared a third supplemental application for Lynozyfic, an injectable treatment listed under BLA761400.
The FDA approved a REMS-related supplemental application for Lynozyfic during the week.
- The FDA approved submission number 3 for LYNOZYFIC (BLA761400), a REMS-class supplement, with an approval letter dated August 4, 2026, and a submission status date of July 31, 2026.1 The listed sponsor name on the record is Rengeneron Pharmaceuticals, Inc.
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