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FDA Approves forzinity for Barth Syndrome
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FDA Grants accelerated Approval to Forzinity for Barth Syndrome Treatment
By Amelia Hernandez | WASHINGTON – 2025/09/20 08:33:07
The Food and Drug Administration (FDA) has given accelerated approval to Forzinity, a new drug developed by Stealth BioTherapeutics, for the treatment of Barth syndrome, a rare genetic condition affecting approximately 150 individuals in the United States.
The FDA’s decision follows extensive discussions between Stealth BioTherapeutics and the agency regarding the data required to demonstrate the drug’s effectiveness
