The NDA is supported by data from the EXCALIBER-RRMM trial, which evaluated the safety and efficacy of iberdomide, an investigational cereblon E3 ligase modulator.
UK Myeloma expert from Oxford, Professor Karthik Ramasamy, Clinical Director, SACT Clinical Reference Group for GenesisCare, based at their centre in Oxford, is leading the SECURE study, one of ...
Darzalex Faspro reduced the risk of disease progression to active multiple myeloma or death by 51% compared with active monitoring. The Food and Drug Administration (FDA) has approved Darzalex Faspro ...
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 ...
The U.S. Food and Drug Administration (FDA) approved on Thursday Johnson & Johnson’s (NYSE:JNJ) Darzalex Faspro (daratumumab and hyaluronidase-fihj) for a type of blood cancer. Darzalex Faspro is the ...
The anti-CD38 mAb daratumumab with hyaluronidase (Darzalex Faspro; Janssen) was approved by the FDA for high-risk smoldering multiple myeloma. The decision was based on results from the open-label, ...
Please provide your email address to receive an email when new articles are posted on . The FDA has approved daratumumab and hyaluronidase-fihj monotherapy as treatment for adults with high-risk ...
Phase 3 AQUILA study showed DARZALEX FASPRO ® significantly reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active monitoring Landmark approval supports ...
Phase 3 AQUILA study showed DARZALEX FASPRO ® significantly reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active ...
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