04/02/2026 Oncolytics Biotech's pelareorep-based regimen received the FDA fast track designation for MSS CRC Oncolytics Biotech's pelareorep-based regimen received the FDA fast track designation for MSS CRC (Ref) The US FDA granted the fast track designation to Oncolytics Biotech's pelareorep (oncolytic virus) in combination with bevacizumab (Avastin®) and FOLFIRI for the treatment of patients with KRAS-mutant, MSS metastatic colorectal cancer in the second-line setting. The

18/09/2025 Replimune completed a Type A meeting with the FDA to discuss the CRL for vusolimogene oderparepvec + nivo (Ref) Replimune announced the completion of a Type A meeting with the US FDA discussing the CRL for the BLA of vusolimogene oderparepvec (RP1; herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF) + nivo for the treatment of anti-PD-1 pretreated advanced melanoma. The feedback from the FDA provided during the me

29/07/2025 Calidi Biotherapeutics' CLD-201 received the US FDA Fast Track Designation for soft tissue sarcoma (Ref) The US FDA granted the Fast Track designation to Calidi Biotherapeutics' CLD-201 (SuperNova; allogeneic adipose stem-cell loaded oncolytic virus) for the treatment of soft tissue sarcoma. Guy Travis Clifton, CMO, Calidi: “FDA IND clearance and Fast Track designation represents an important milestone in the development of CLD-201. This designation underscores the

22/07/2025 Replimune's BLA for vusolimogene oderparepvec + nivo received a CRL from the US FDA (Ref) The US FDA issued a Complete Response Letter (CRL) regarding the BLA for Replimune's vusolimogene oderparepvec (RP1; herpes simplex virus engineered with a fusogenic protein (GALV-GP R-) and GM-CSF) + nivolumab for the treatment of advanced melanoma. The CRL highlighted that the FDA was unable to approve the application in its present form due to the following reasons: The Ph1