January 2nd Week, 2026 Regulatory Events 🎯  Summit Therapeutics, Inc.  has submitted a biologics license application to the US FDA seeking approval for  Akeso Biopharma  & Summit's ivonescimab (PD-1 x VEGF BsAb) + chemotherapy in second-line or later treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC. (Ref 1) ❓ What are the launch timeline estimates for the regimen in this indication?   Special Designations ⭐ The US FDA granted the rege

04/08/2025 Alphamab's IND application for JSKN022 was accepted by China's CDE ( Ref ) Alphamab Oncology's IND application for JSKN022...

24/06/2025 CARsgen Therapeutics submitted a NDA for Satri-cel to China’s NMPA ( Ref ) CARsgen Therapeutics submitted the New Drug...

June 3rd week, 2025 Regulatory Updates    🎯  Senti Biosciences  received an ODD from the US FDA for SENTI-202 (off-the-shelf CD33 and/or...

June 2nd week, 2025 ⭐ Deals & Collaborations   🤝Neowise Biotechnology granted  BeOne Medicines  rights to one of its proprietary...

May 5th & June 1st Week ⭐ Regulatory Updates   🎯 China’s NMPA granted Priority Review to  CARsgen Therapeutics ’ satri-cel (CT041; an...

May 3rd Week, 2025 ⭐ Regulatory Update   🎯 The US FDA granted the RMAT designation to  BrainChild Bio ’s BCB-276 (an autologous, B7-H3...

April 3rd & 4th, 2025 Regulatory Updates   🎯 The UK MHRA granted conditional marketing authorization for  Autolus Therapeutics ’...

March 3rd Week, 2025 Regulatory Events 🎯 The European commission granted approval to  Bristol Myers Squibb ’ Breyanzi (lisocabtagene...

February 4th Week, 2025 📝 The US FDA granted RMAT designation for   ImmunityBio ’s Anktiva (n ogapendekin alfa inbakicept; IL-15...

February 3rd Week, 2025 📝 BMS’ Breyanzi (liso-cel; an autologous, anti-CD19 CAR-T) received NICE recommendation as an option for...

February 2nd Week, 2025 📝 BMS’ Phase 2 TRANSCEND FL trial of Breyanzi (lisocabtagene maraleucel; an autologous, anti-CD19 CAR-T) met...

Highlights from the Committee for Medicinal Products for Human Use (CHMP) January 2025 Meeting are out! Here are the positive...

Welcome to the May edition of our CGT Watch newsletter!   CARsgen’s satri-cel priority review & Ph2 results; Autolus’ obe-cel positive...

Dear Readers, Welcome to our inaugural CGT Watch newsletter! We’re excited to bring you monthly highlights on novel targets, innovative...

PD-(L)1 axis inhibits CAR-T cell activation, proliferation, survival, and functionality. Thus, CAR-T mediated direct targeting of the...