Orphan designation: 1-(3-Bromobenzyl)-N3-(3,4-dichlorophenyl)-1H-1,2,4-triazole-3,5-diamine Treatment of radiation induced maculopathy, 20/06/2025 Positive
Orphan designation: 3-(Carbamoylamino)-5-[2-(3-fluorophenyl)ethynyl]-N-[(3S)-piperidin-3-yl]thiophene-2-carboxamide hydrochloric acid Treatment of acute myeloid leukaemia, 20/06/2025 Positive
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2025
First reformulation of an inhaled medicine with environmentally friendly gas propellant
Summary of opinion: Baqsimi, 24/07/2025 Positive
Summary of opinion: Sirturo, 24/07/2025 Positive
Summary of opinion: Clopidogrel Zentiva (previously Clopidogrel Winthrop), 24/07/2025 Positive
Summary of opinion: Tevimbra, 24/07/2025 Positive
New injection for easier prevention of HIV infection in the EU and worldwide
Orphan designation: 3-((4-(1-((1-(6-(((S)-2,6-Dioxopiperidin-3-yl)carbamoyl)pyridin-3-yl)piperidin-4-yl)methyl)piperidin-4-yl)phenyl)amino)-5-((R)-3-(3-methyl-2-oxoimidazolidin-1-yl)piperidin-1-yl)pyrazine-2-carboxamide Treatment of lymphoplasmacytic lymphoma, 20/06/2025 Positive