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Regeneron Showcases Updated on BLA for Linvoseltamab to Treat R/R Multiple Myeloma (MM)

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Regeneron

Regeneron Showcases Updated on BLA for Linvoseltamab to Treat R/R Multiple Myeloma (MM)

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  • The US FDA has issued a CRL related to the BLA for Linvoseltamab for the treatment of 3L+ r/r MM. Regeneron presented results and during its Q2’24 earnings call.
  • As per Regeneron, pre-approval inspection at a third-party fill/finish manufacturer has been completely and awaiting FDA re-inspection in next few months and expecting to receive resolution and approval.
  • Linvoseltamab is a bispecific antibody that promotes the interaction of BCMA x CD-3 expressing T-cell on MM cells. Regeneron's Linvoseltamab is under regulatory review by the EMA for the same indication

Ref: Regeneron | Image: Regeneron

Related News:- Regeneron Showcases Updated P-I/II (LINKER-MM1) Study Data of Linvoseltamab for Treating R/R Multiple Myeloma at EHA 2024

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Dipanshu Dixit

A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies. He can be contacted at connect@pharmashots.com

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