Posted by Michael Wonder on 23 Aug 2023
Geron announces PDUFA date for imetelstat NDA in lower risk MDS
22 August 2023 - Geron Corporationtoday announced that the US FDA has assigned a standard review and a PDUFA action date of 16 June 2024 for Geron’s new drug application for imetelstat for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes.
In addition, the FDA informed the Company that it is currently planning to hold an advisory committee meeting as part of the new drug application review.
