02:21 PM EST, 11/19/2025 (MT Newswires) -- Johnson & Johnson's ( JNJ ) Janssen Biotech unit has been granted traditional approval to Darzalex Faspro with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light chain amyloidosis, the US Food and Drug Administration said Wednesday.

The approval for Darzalex, with active ingredients daratumumab and hyaluronidase-fihj, was based on major organ deterioration progression free survival and overall survival, the FDA said.

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