06/11/2025 Johnson & Johnson's Darzalex Faspro has been approved by the FDA for HR-SMM ( Ref ) The US FDA approved Johnson & Johnson's Darzalex Faspro® (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). The approval is based on results from the Ph3 AQUILA/NCT03301220 trial, which evaluated the efficacy and safety of Darzalex Faspro vs active monitoring (or “Watch and Wait”) in patients with

09/09/2025 Johnson & Johnson's INLEXZO received US FDA approval for NMIBC ( Ref ) The US FDA approved Johnson & Johnson's INLEXZO™...

17/07/2025 Johnson & Johnson received Priority Review for TAR-200 from the US FDA in high-risk non-muscle invasive bladder cancer ( Ref )...