09/02/2026 Krystal Biotech's KB707 received the FDA RMAT Designation for advanced or metastatic NSCLC Krystal Biotech's KB707 received the FDA RMAT Designation for advanced or metastatic NSCLC ( Ref ) The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Krystal Biotec's KB707 (redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 and interleukin-12 in the tumor microenvironment) for the treatment of advanced

23/12/2025 Alphamab Oncology and 3D (Beijing) Medicines' envafolimab received the FDA orphan drug designation for GC/GEJC SN Bioscience's SNB-101 received the FDA orphan drug designation for GC/GEJC Alphamab Oncology and 3D (Beijing) Medicines' envafolimab received the FDA orphan drug designation for GC/GEJC ( Ref ) The US FDA granted the orphan drug designation to Alphamab Oncology and 3D (Beijing) Medicines' envafolimab (KN035; subcutaneously injectable PD-L1 inhibitor) for