Welcome to the January edition of our CGT Watch newsletter! Stay informed on the latest advancements in the CGT space—subscribe now to receive insightful updates straight to your inbox. Dear Readers, We’re excited to bring you Jan edition of CGT watch highlighting updates on novel targets, innovative approaches, first-of-its-kind combinations, and key developments. Since we’re keen to keep things concise and focused, this issue will exclusively cover cell therapies. 🎯 Regula

10/12/2025 GSK's risvutatug rezetecan received the FDA orphan drug designation for SCLC Ajax Therapeutics' AJ1-11095 received the FDA orphan drug designation for myelofibrosis GSK's risvutatug rezetecan received the FDA orphan drug designation for SCLC ( Ref ) The US FDA granted the orphan drug designation to GSK's risvutatug rezetecan (B7-H3-targeted ADC) for the treatment of small-cell lung cancer (SCLC). The ODD was based on preliminary clinical data of the Phase 1 ARTEMIS

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 approva

26/11/2025 BeOne's sonrotoclax received the priority review status for R/R MCL ( Ref ) The US FDA granted priority review status to BeOne Medicines' NDA for sonrotoclax (BCL2 inhibitor) for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase (BTK) inhibitor. The NDA is supported by results from the global Phase 1/2 BGB-11417-201 (NCT05471843) trial Lai Wang, Ph.D., Global Head of R&D

30/09/2025 Umoja Biopharma's UB-VV111 in vivo CAR T cell therapy received the FDA fast track designation for B-Cell Malignancies ( Ref )...