Industry News and Headlines

FDA Clears New Formulation of Lantheus' PSMA Imaging Agent

The FDA has cleared Pylarify TruVu, a reformulated version of Lantheus’ PSMA‑targeting radiopharmaceutical piflufolastat F‑18. The new formulation improves stability at higher radioactive concentrations, enabling larger batch production and broader distribution. Lantheus plans a Q4 2026 commercial launch with a rolling geographic rollout to ease the transition from the original Pylarify. Guidelines from NCCN and EAU now list PSMA PET as preferred imaging for high‑risk prostate cancer, underscoring the agent’s clinical relevance.