04/12/2025 BMS' Breyanzi received FDA approval for R/R MZL J & D Pharmaceuticals' investigational therapy received the FDA orphan drug designation for HCC BMS' Breyanzi received FDA approval for R/R MZL (Ref) The US FDA granted approval to Bristol Myers Squibb's lisocabtagene maraleucel (Breyanzi; CD19-directed CAR-T cell therapy) for the treatment of adult patients with R/R marginal zone lymphoma who have received at least two prior lines of systemic therapy. The approval

June 3rd week, 2025 Regulatory Updates 🎯 Senti Biosciences received an ODD from the US FDA for SENTI-202 (off-the-shelf CD33 and/or FLT3 targeting CAR-NK) for R/R AML (Ref 1) 👉 Why it matters: This is the first logic-gated CAR-NK with clinical data, demonstrating encouraging early results (ORR of 71.4% (n=7) with responses sustained beyond 8 months) 🎯 The US FDA granted ODD for CERo Therapeutics, Inc.’ CER-1236 (anti-TIM-4L CER-T), which is being evaluated in Ph1...