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 BNT11

25/08/2025 Quest Diagnostics' Haystack MRD® test received the Breakthrough Device Designation from the FDA for colorectal cancer (Ref) The US FDA granted the Breakthrough Device Designation for Quest Diagnostics' Haystack MRD® test for identifying MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling. Dan Edelstein, Vice President and General Mana