Posted by Michael Wonder on 30 Sep 2023
Geron announces EMA validation of marketing authorisation application for imetelstat for the treatment of lower risk MDS
29 September 2023 - Geron Corporation today announced that the EMA has validated the marketing authorisation application for imetelstat, a first-in-class investigational telomerase inhibitor, for the treatment of transfusion-dependent anaemia in patients with lower risk myelodysplastic syndromes.
The marketing authorisation application was submitted earlier this month and is now under regulatory review by the European CHMP under the centralised procedure, which applies to all 27 EU member states, Iceland, Norway and Liechtenstein.
