21/01/2026 BioNTech's BNT113 + pembro received the FDA fast track designation for HPV16+ R/M SCCHN with PD-L1 CPS ≥1 Wugen's soficabtagene geleucel received the FDA Breakthrough Therapy Designation for T cell malignancies Opna Bio's zavabresib received the FDA orphan drug designation for myelofibrosis BioNTech's BNT113 + pembro received the FDA fast track designation for HPV16+ R/M SCCHN with PD-L1 CPS ≥1 ( Ref ) The US FDA granted the fast track designation to BioNTech's BNT

December 2nd Week, 2025 Regulatory Events   🎯 The US FDA granted approval to  Johnson & Johnson Innovative Medicine 's sNDA for niraparib and abiraterone acetate dual-action tablet (PARB inhibition and novel hormonal therapy) + prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication?   Clinical Events 🔬 The Phase 3 STAR-221 trial o

November 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted full approval to  Kura Oncology, Inc.  and  Kyowa Kirin Co., Ltd. 's ziftomenib (menin inhibitor) for adult patients with R/R AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. (Ref 1) ❓ How is this approval expected to impact the Tx algorithm of AML? Clinical Events 🔬 In the Phase 3 PEAK trial,  Cogent Biosciences ' bezuclastinib (KIT inhibitor) + sunitinib met the prim

November 1st Week, 2025 Regulatory Events 🎯 The US FDA approved  Johnson & Johnson 's Darzalex Faspro (daratumumab, an anti-CD38, and hyaluronidase) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of this indication? Clinical Events 🔬 In the registrational cohort of the Phase 2 IOV-LUN-202/NCT04614103 trial,  Iovance Biotherapeutics, Inc. ’s lifileuc

August 2nd Week, 2025 Regulatory Events   🎯 The US FDA granted accelerated approval to  Boehringer Ingelheim 's zongertinib (kinase...

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

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

Welcome to the April edition of our CGT Watch newsletter!   Autolus’ Aucatzyl’s UK approval; BrainChild Bio’s BCB-276 BTD; Lyell’s LYL314...