Orphan designation: 2-(3-(4-(1H-Indazol-5-ylamino)quinazolin-2-yl)phenoxy)-N-isopropylacetamide-methane sulfonic acid salt Treatment of graft-versus-host disease, 17/10/2019 Positive

First treatment for serious chronic lung disease

Opinion/decision on a Paediatric investigation plan (PIP): Rezzayo, rezafungin acetate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0343/2024

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 October 2025

Summary of opinion: Libtayo, 16/10/2025 Positive

Summary of opinion: Breyanzi, 16/10/2025 Positive

Summary of opinion: Gazyvaro, 16/10/2025 Positive

Summary of opinion: Cejemly, 16/10/2025 Positive

Summary of opinion: Pyrukynd, 16/10/2025 Positive

EMA confirms suspension of sickle cell disease medicine Oxbryta