GSK

GSK NEWSROOM (143 press releases)

GlaxoSmithKline: Die Europäische Arzneimittel-Agentur (EMA) validierte den Antrag auf Marktzulassung (MAA) für Daprodustat, einen oralen Hypoxie-induzierbaren Faktor-Prolylhydroxylase-Hemmer zur Behandlung von Patienten mit Anämie bei chronischer Nierenerkrankung

PRESS RELEASE -- 1, March 2022

Zulassungsantrag für die Behandlung von Anämie bei chronischer Nierenerkrankung basierend auf dem klinischen Phase-III-Studienprogramm ASCEND, bestehend aus fünf Studien, die alle ihre co-primären Wirksamkeits- und Sicherheitsendpunkte erreichten Die Zulassung der EMA-Anträge ist der erste große regulatorische Meilenstein für Daprodustat seit … Read the full press release →

GlaxoSmithKline: European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor used to treat patients with anaemia of chronic kidney disease

PRESS RELEASE -- 1, March 2022

Submission for the treatment of anaemia of chronic kidney disease based on the ASCEND Phase III clinical trial programme, consisting of five trials that all met their co-primary efficacy and safety endpoints EMA file acceptance is the first major regulatory … Read the full press release →

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