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FDA Grants First-Ever Approval for Barth Syndrome Treatment in Males, ETHealthworld

Pelican Press

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Bengaluru: The U.S. Food and Drug Administration said on Friday it had approved Stealth Biotherapeutics’ once-daily injection for a rare, genetic disease that primarily affects males, making it the first treatment to be greenlit for the condition. Stealth’s Forzinity was granted accelerated approval for treating Barth syndrome, in patients weighing at least 30 kg. Barth syndrome is a rare…

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