🇺🇸 piflufolastat F 18 in United States

FDA authorised piflufolastat F 18 on 6 March 2026

Marketing authorisation

FDA — authorised 6 March 2026

• Application: NDA220089
• Marketing authorisation holder: APHELION
• Local brand name: PYLARIFY TRUVU
• Indication: SOLUTION — INTRAVENOUS
• Status: approved

The FDA approved piflufolastat F 18, marketed as PYLARIFY TRUVU, for intravenous use. This approval was granted to APHELION following a standard review pathway. The exact indication for piflufolastat F 18 is not specified in the provided information.

Read official source →

Frequently asked questions

Is piflufolastat F 18 approved in United States?

Yes. FDA authorised it on 6 March 2026.

Who is the marketing authorisation holder for piflufolastat F 18 in United States?

APHELION holds the US marketing authorisation.