piflufolastat F 18 (Pylarify TruVu): FDA status

Approved Approved Mar 6, 2026. Indication: PSMA PET imaging in prostate cancer. Company: Lantheus Holdings.

Regulatory history

• Mar 6, 2026: Approved. FDA approved Pylarify TruVu a higher concentration stable formulation of piflufolastat F18 for PSMA PET imaging in prostate cancer urologytimes.com
• Aug 6, 2025: FDA accepted for review. FDA accepted NDA for new higher concentration formulation of piflufolastat F 18 with PDUFA date of March 6 2026. onclive.com

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