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

09/10/2025 Adcendo's ADCE-D01 received the FDA fast track designation for the treatment of STS ( Ref ) The US FDA granted the fast track...

10/09/2025 Greenwich LifeSciences' GLSI-100 received the FDA fast track designation for HER2+ve breast cancer ( Ref ) The US FDA granted...

06/08/2025 Jazz Pharmaceuticals' Modeyso received accelerated approval from the FDA for Recurrent H3 K27M-mutant Diffuse Midline Glioma (...

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

09/07/2025 Artera's ArteraAI Prostate received the Breakthrough Device designation from the US FDA ( Ref ) The US FDA granted the...