Johnson & Johnson announced the submission of regulatory applications to the U.S. FDA and European Medicines Agency seeking approval of a new indication for Darzalex Faspro in the U.S. and Darzalex subcutaneous formulation in the European Union. The applications are supported by data from the ongoing Phase 3 AQUILA study of Darzalex Faspro as monotherapy for the treatment of adult patients with high-risk smoldering multiple myeloma.
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