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an FDA advisory review is scheduled for July 2026, with agency staff already recommending against approval

doi: 10.3389/fphar.2025.1602976 Received 30 March 2025 Revised 13 November 2025 Accepted 14 November 2025 Published 19 December 2025 Volume 16 - 2025 Edited by Bernd Rosenkranz, Fundisa African Academy of Medicines Development, South Africa Reviewed by Kacper Nijakowski, Poznan University of Medical Sciences, Poland Miriam Njoki Karinja, Science for Africa Foundation, Kenya Updates Copyright 2025 Mazur, Ndokaj, Salerno, Vallone, Ardan, Bietolini, Carrouel, Wilk, Sarig, Ottolenghi and Bourgeois

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doi: 10.1038/ejhg.2009.187 367 UlrichG.SalvadA.BoersemaP.CalT.FoglieniC.SolaM.et al