Janssen is seeking to extend approval of its under-the-skin formulation of Darzalex (daratumumab) to include its use in combination with Pomalyst (pomalidomide) and dexamethasone to treat relapsed or refractory multiple myeloma patients who received at least one prior line of therapy. The company submitted applications for this combination therapy to regulatory agencies in the U.S. and the European Union. Darzalex as a subcutaneous injection treatment is available as Darzalex Faspro in the U.S., and as Darzalex SC across the EU. Janssen’s…
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