23/09/2026 US FDA approves LYRFIGTU™ (lirafugratinib) in FGFR2-Altered Cholangiocarcinoma SOTIO Advances SOT106 with Additional FDA Designations in Sarcoma In Phase 3 MajesTEC-3 study, TECVAYLI + DARZALEX FASPRO demonstrates durable survival outcomes and substantial progression risk reduction in RRMM US FDA approves LYRFIGTU™ (lirafugratinib) in FGFR2-Altered Cholangiocarcinoma (Ref) Elevar Therapeutics announced US FDA approval of LYRFIGTU™ (lirafugratinib), an irreversible

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 HR