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Previously Rejected Drug Approved as First Barth Syndrome Treatment

The FDA on Friday granted accelerated approval to elamipretide (Forzinity) as the first treatment for the ultra-rare Barth ...

Stealth BioTherapeutics Announces FDA Accelerated Approval of FORZINITY™ (elamipretide HCl), the First Therapy for Progressive and Life-limiting Ultra-rare Gen…

Stealth BioTherapeutics Inc. (the "Company" or "Stealth"), a commercial-stage biotechnology company focused on the discovery, ...
Fierce Pharma

FDA greenlights Stealth Bio's injection as 1st treatment for Barth syndrome

Stealth’s injection, known as elamipretide, will be sold as Forzinity for the treatment of Barth syndrome, an X-linked ...

3 FDA approval firsts that could be around the corner

The industry’s final months of 2025 could be action-packed as the FDA renders approval decisions on drugs that would be ...
MPR

Forzinity Gets Accelerated Approval for Barth Syndrome

The Food and Drug Administration (FDA) has granted accelerated approval to Forzinity ™ (elamipretide HCl) to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at ...