Xspray Pharma receives CRL from US FDA for Nilopki

Xspray Pharma

4 June 2026 - Xspray Pharma has received a complete response letter from the US FDA for its new drug application for Nilopki, an optimised formulation of nilotinib. 

The company will address remaining questions with FDA; long‑term strategy and HyNap platform remain unchanged.

Read XSpray Pharma press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Registration