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Halozyme Therapeutics Announces Johnson & Johnson Gets US FDA's Approval Of New Indication For DARZALEX Faspro Co-formulated With ENHANZE To Treat Smoldering Multiple Myeloma

Author: Benzinga Newsdesk | November 07, 2025 08:31am

Halozyme Therapeutics, Inc. (NASDAQ:HALO) (Halozyme) today announced that Johnson & Johnson received U.S. Food and Drug Administration (FDA) approval of a new indication for DARZALEX Faspro® (daratumumab and hyaluronidase-fihj) co-formulated with ENHANZE®, as single agent treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM). DARZALEX Faspro® is the first and only approved treatment for HR-SMM, enabling earlier intervention before the disease progresses to active multiple myeloma.

 

Posted In: HALO JNJ


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