13/04/2026 FDA issues Complete Response Letter to Replimune’s RP1 BLA, halting accelerated approval path FDA Grants Priority Review for Ifinatamab Deruxtecan in ES-SCLC Daraxonrasib Demonstrates Unprecedented Survival Benefit in Phase 3 Pancreatic Cancer Trial Jaypirca (pirtobrutinib) combination significantly extended progression-free survival (PFS) in Relapsed/Refractory CLL/SLL SynOx Therapeutics' Phase 3 TANGENT Study Delivers Positive Results for TGCT Treatment IDEAYA an

19/11/2025 Roche's Lunsumio SC received conditional approval in EU for R/R FL (Ref) The European Commission granted conditional marketing authorisation to Roche's mosunetuzumab (Lunsumio; CD20 x CD3 bispecific antibody) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The approval is based on results from the Phase I/II GO29781 trial in which Lunsumio SC had pharmacok

May 4th Week, 2025 Regulatory Events 🎯 The US FDA granted a Fast Track designation to CSPC Pharmaceutical Group ’s CPO301 (SYS6010; EGFR ADC) for the Tx of oncogenic driver mutation negative, non-squamous NSCLC patients who have progressed on prior platinum chemotherapy and anti-PD-(L)1 therapy. (Ref 1) ❓ Which other ADCs are being developed for this setting? 🎯 Zai Lab's ZL-1310 (DLL3 ADC) was granted a Fast Track designation by the US FDA for the Tx of ES-SCLC patients