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.

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 ...

Johnson & Johnson shows strong progress in oncology with Darzalex sales and regulatory filings, leading to a 'Buy' rating ...

Darzalex Faspro looks set to transform the prospects for the 30,000 to 45,000 people in the US and Europe AL amyloidosis patients. It has already been submitted for approval in the EU.

(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 ...

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

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

We also project no impact on our U.S. or European royalty revenues on sales of DARZALEX FASPRO and SC through 2032. Additionally, this decision has no impact on the ability of any other Halozyme ...

Looking a bit deeper, it looks as if ENHANZE's top therapies like Johnson & Johnson's (JNJ) DARZALEX Faspro (Sub-Q), and Roche's (OTCQX:RHHBY) Phesgo helped pull in $155M in royalty revenues ...

We also project no impact on our U.S. or European royalty revenues on sales of DARZALEX FASPRO and SC through 2032. Additionally, this decision has no impact on the ability of any other Halozyme ...