Gregory A. Demopulos, M.D.

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While this decision does not allow us to begin labeling discussions now, it does provide paths forward based on collecting historical data with or without an independent literature review. — On 2022 FDA dispute resolution decision

from First treatment approved for deadly stem cell transplant complication · Updated May 23

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First treatment approved for deadly stem cell transplant complication

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Leading company through first commercial launch

For decades, patients with transplant-associated thrombotic microangiopathy (TA-TMA) after stem cell transplants faced no FDA-approved treatment—mortality rates reached 80-90% for severe cases. In December 2025, the FDA approved Yartemlea, the first therapy for TA-TMA.

Updated May 23

Gregory A. Demopulos, M.D.

Notable Quotes

Stories

First treatment approved for deadly stem cell transplant complication

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