thecardiologyadvisor.com2d
FDA Extends Review of Elamipretide for Barth Syndrome
The FDA has extended the review period for the New Drug Application for elamipretide for the treatment of Barth syndrome.
Johns Hopkins Medicine6d
Cushing's Syndrome
What is Cushing's syndrome? Cushing's syndrome is a hormonal disorder. It’s caused when you have high levels of the hormone cortisol over a long time. Cushing's syndrome is fairly rare. It most often ...
Stealth faces another hurdle as FDA delays decision on Barth syndrome drug
The FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.
The Pharma Letter6d
FDA delays PDUFA action date for elamipretide
US clinical-stage drug developer Stealth BioTherapeutics announced that the US Food and Drug Administration (FDA) has ...