FDA Approved DARZALEX Faspro® for Adult Patients with High-Risk Smoldering Multiple Myeloma

Accessibility StatementSkip Navigation DARZALEX Faspro® is co-formulated with Halozyme's ENHANZE® drug delivery technology SAN DIEGO, Nov. 7, 2025 /PRNewswire/ -- 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- ...