The FDA has extended the review period for the New Drug Application for elamipretide for the treatment of Barth syndrome.
The new Prescription Drug User Fee Act target date is April 29, 2025. The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elamipretide for ...
The US Food and Drug Administration (FDA) has delayed its decision on Stealth BioTherapeutics’ new drug application (NDA) for elamipretide, a treatment for the ultra-rare disease Barth syndrome.
Our lead product candidate, elamipretide, is under review for Barth syndrome and in late-stage development for primary mitochondrial myopathy and dry age-related macular degeneration. We are also ...
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Stealth faces another hurdle as FDA delays decision on Barth syndrome drugThe FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.
If approved, this would be the first marketing authorization for elamipretide, a first-in-class mitochondria-targeted therapeutic, and the first FDA-approved therapy for Barth syndrome.
Three months ago, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-6 in support of elamipretide becoming the first approved treatment for Barth syndrome, an X-linked genetic ...
The same year Smith proposed his wife is the year he won the NASCAR Truck Series championship, securing the title after scoring four wins, 14 Top 5s and 19 Top 10 finishes. His championship win ...
Our lead product candidate, elamipretide, is under review for Barth syndrome and in late-stage development for primary mitochondrial myopathy and dry age-related macular degeneration. We are also ...
Plus, news about Valneva and Ab&B Bio-Tech: FDA delays decision on Stealth BioTherapeutics drug to April 29: The company’s elamipretide is being developed for Barth … ...
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