Posted by Michael Wonder on 14 Jan 2026
FDA confirms a PDUFA goal date of 30 August 2026 for the sBLA submission of ropeginterferon alfa-2b-njft in essential thrombocythemia
13 January 2026 - PharmaEssentia today announced that the US FDA has accepted the Company’s supplemental biologics license application for ropeginterferon alfa-2b-njft for the treatment of adult patients with essential thrombocythemia.
The review classification for this application is Standard. The user fee target date is 30 August 2026.
