US FDA declines to approve Fortress Bio and Zydus' treatment for a rare pediatric disease

Reuters

2025/10/01

Oct 1 (Reuters) - The U.S Food and Drug Administration on Wednesday declined to approve Fortress Biotech FBIO.O and Indian drugmaker Zydus Lifesciences' ZYDU.NS drug for a type of rare genetic disease in children, Fortress said.

(Reporting by Padmanabhan Ananthan and Sneha S K in Bengaluru; Editing by Vijay Kishore)

((Padmanabhan.Ananthan@thomsonreuters.com;))

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