The marketing applications with the EMA and FDA are for J&J and partner Genmab's Darzalex Faspro version of the anti-CD38 ...

J&J’s filing is based on results from the phase 3 AQUILA trial. Among 390 patients with high-risk smoldering multiple myeloma ...

If approved by the FDA, Darzalex Faspro may be the first treatment for smoldering multiple myeloma as compared to treating the disease once it progresses.

Johnson & Johnson announced the submission of regulatory applications to the U.S. FDA and European Medicines Agency seeking approval of a ...

(RTTNews) - Johnson & Johnson (JNJ), Friday announced the submission of regulatory applications for Darzalex Faspro to the U.S. Food and Drug Administration, and Darzalex to the European Medicines ...

Johnson & Johnson seeks US & EU approvals for Darzalex Faspro/Darzalex as subcutaneous monotherapy for high-risk smoldering multiple myeloma: Raritan, New Jersey Monday, November ...

New Darzelex SC quadruplet regimen approved by European Commission for newly diagnosed multiple myeloma patients.

Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody ...

Halozyme's Q3 earnings exceeded expectations, with a $1.27 EPS and 34% YoY revenue growth, driven by ENHANZE tech and strong ...

Raritan: Johnson & Johnson has announced the submission of regulatory applications to the U.S. Food and Drug Administration ...

The European label for Johnson and Johnson Innovation Medicine’s (J&J) Darzalex (daratumumab) has been expanded to include patients with newly diagnosed multiple myeloma (MM) eligible for ...

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