Shots
Pelareorep is gaining regulatory momentum through multiple FDA interactions and Fast Track designations, providing greater clarity around potential registration pathways and shaping Oncolytics’ clinical development and partnership strategy.
REO-033 could mark a pivotal step toward registration as the randomized study in RAS-mutant MSS metastatic colorectal cancer builds on encouraging clinical data and has the potential to become…
Shots:
The US FDA has accepted the resubmitted NDA for TLX101-Px (Pixclara; 18F-FET), an investigational PET imaging agent for the detection and characterization of glioma in adult and pediatric patients
The US FDA has assigned a PDUFA date of 11’Sep, 2026; TLX101-Px has received Orphan Drug and Fast Track designations, addressing unmet needs in distinguishing…

