18/08/2026 BH-30643 earns US FDA Fast Track designation for pretreated NSCLC FDA Endorses Registrational Path for Pelareorep in RAS‑Mutant MSS Colorectal Cancer PLN-101095 Secures US FDA Fast Track for ICI-Refractory Solid Tumors US FDA Grants Fast Track to ETX‑19477, a Novel PARG Inhibitor for BRCA‑Mutated Breast Cancer BH-30643 earns US FDA Fast Track designation for pretreated NSCLC (Ref) BlossomHill Therapeutics announced that its investigational drug BH-30643, a macrocyc

20/07/2026 US FDA Fast Track Designation Secured for Pelareorep in Advanced Anal Cancer US FDA Grants Tentative Approval for NATCO’s Generic Olaparib US FDA Fast Track Designation Secured for Pelareorep in Advanced Anal Cancer (Ref) Oncolytics Biotech's Pelareorep (double-stranded RNA immunotherapy), in combination with a checkpoint inhibitor, received Fast Track designation for second-line and later squamous cell carcinoma of the anal canal (SCAC) patients who progressed aft

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