MPN Watch

Dossier web other 13-jan-2026

FDA Confirms PDUFA Goal Date of August 30, 2026 for Ropeginterferon Alfa-2b-njft sBLA in Essential Thrombocythemia

Key claim: The FDA has accepted PharmaEssentia’s supplemental Biologics License Application for ropeginterferon alfa-2b-njft in adult essential thrombocythemia, setting a PDUFA goal date of August 30, 2026.

Abstract

FDA accepted PharmaEssentia’s supplemental Biologics License Application for ropeginterferon alfa-2b-njft for treatment of adult ET patients, with a user fee target date of August 30, 2026 and determination that the submission is sufficiently complete to proceed with substantive review.

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Briefing card

FDA Confirms PDUFA Goal Date of August 30, 2026 for Ropeginterferon Alfa-2b-njft sBLA in Essential Thrombocythemia
Stage: other · web · 13-jan-2026

The FDA has accepted PharmaEssentia's supplemental Biologics License Application for ropeginterferon alfa-2b-njft in adult essential thrombocythemia, setting a PDUFA goal date of August 30, 2026.

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External: url:https://www.biospace.com/press-releases/fda-confirms-a-pdufa-goal-date-of-august-30-2026-for-the-sbla-submission-of-ropeginterferon-alfa-2b-njft-in-essential-thrombocythemia-et

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