11/11/2025 Allterum Therapeutics' 4A10 received the FDA fast track designation for ALL ( Ref ) The US FDA granted the fast track designation to Allterum Therapeutics' 4A10 (anti-IL-7Rα) for the treatment of patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL). Yan Moore, CEO, Allterum Therapeutics: " The FDA's Fast Track designation for 4A10 affirms its potential and empowers us to work hand-in-hand with the agency to bring this therapy to patients and fami

28/10/2025 Alphamab Oncology's JSKN003 received the FDA fast track designation for PROC ( Ref ) The US FDA granted the fast track designation to Alphamab Oncology's JSKN003 (biparatopic HER2-targeting antibody-drug conjugate) for the treatment of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC). To note, in Sep'24, Alphamab  entered a licensing agreement with JMT-Bio Technology (a wholly-

16/09/2025 Corbus and CSPC Pharma's CRB-701 ADC received the FDA Fast Track Designation for R/M HNSCC ( Ref ) The US FDA granted the Fast...

09/09/2025 Johnson & Johnson's INLEXZO received US FDA approval for NMIBC ( Ref ) The US FDA approved Johnson & Johnson's INLEXZO™...

31/07/2025 MaxCyte and Anocca AB signed a Strategic Platform Licensing Agreement to advance TCR-T cell therapies ( Ref ) MaxCyte signed a...

28/07/2025 sNDA for Akeso and Summit's ivonescimab (PD-1 x VEGF bispecific antibody) + chemotherapy for sqNSCLC accepted by China's NMPA...

22/07/2025 Replimune's BLA for vusolimogene oderparepvec + nivo received a CRL from the US FDA ( Ref ) The US FDA issued a Complete...

10/07/2025 TEVIMBRA + chemotherapy has been approved in EU as a first-line treatment for NPC ( Ref ) The EC approved BeOne Medicines'...

01/07/2025 HanchorBio and Henlius signed a ~$200M licensing deal for HanchorBio's HCB101 ( Ref ) HanchorBio and Shanghai Henlius Biotech...

12/06/2025 MAIA Biotechnology and Roche announce a master clinical supply agreement for hard-to-treat cancer therapies ( Ref ) MAIA...