Elamipretide receives orphan drug designation

Stealth BioTherapeutics Receives Orphan Drug Designation from ...

Stealth BioTherapeutics Receives Orphan Drug Designation from FDA for Elamipretide for Treatment of Duchenne Muscular Dystrophy. Press ...

Stealth BioTherapeutics Receives Orphan Drug Designation from ...

The trial is evaluating two doses of elamipretide in patients with Friedreich's ataxia to assess safety, visual function, and cardiac function.

Elamipretide Wins FDA Orphan Drug Designation to Treat DMD

The U.S. Food and Drug Administration (FDA) has granted orphan drug status to elamipretide for treating Duchenne muscular dystrophy (DMD).

Search Orphan Drug Designations and Approvals - FDA

Generic Name: elamipretide. Date Designated: 03/22/2018. Orphan Designation: Treatment of Barth syndrome. Orphan Designation Status: Designated.

Stealth BioTherapeutics Receives Orphan Drug Designation from ...

The US Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to elamipretide for the treatment of ...

Stealth Clinches Orphan Drug Designation in DMD - BioSpace

Stealth BioTherapeutics has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for elamipretide.

Stealth BioTherapeutics Receives Orphan Drug Designation from ...

The European Medicines Agency (EMA) has granted orphan drug designation (ODD) for elamipretide for the treatment of myopathic mitochondrial DNA depletion ...

Stealth BioTherapeutics Receives Orphan Drug Designation from ...

Stealth BioTherapeutics Receives Orphan Drug Designation from the European Medicines Agency for Elamipretide for the Treatment of Myopathic ...

Elamipretide - Friedreich's Ataxia Research Alliance

HOW DOES A DRUG GET DEVELOPED? ... Stealth BioTherapeutics Receives Orphan Drug Designation from FDA for Elamipretide for the Treatment of Friedreich's Ataxia.

EU/3/22/2614 - orphan designation for treatment of myopathic ...

This means that the developer will receive scientific and regulatory support from EMA to advance their medicine to the stage where they can ...

Stealth Bio's Elamipretide Gets Orphan Drug Designation From FDA ...

(RTTNews) - Stealth BioTherapeutics Corp. (MITO) said on Monday that its drug candidate Elamipretide has been granted orphan drug ...

FDA Grants Orphan Drug Designation to Elamipretide for DMD

The FDA granted Orphan Drug Designation to Stealth BioTherapeutic's elamipretide for patients with Duchenne muscular dystrophy (DMD).

STEALTH BIOTHERAPEUTICS ANNOUNCES FDA ACCEPTANCE ...

Elamipretide received Fast Track Designation in 2017, Orphan Drug Designation in 2018 and Rare Pediatric Disease Designation in 2020.

Elamipretide Gets Orphan Drug Status for Friedreich Ataxia - MPR

The Food and Drug Administration has granted Orphan Drug designation for to elamipretide for the treatment of Friedreich ataxia.

Stealth BioTherapeutics Receives Orphan Drug Designation from ...

Stealth BioTherapeutics Receives Orphan Drug Designation from FDA for Elamipretide for Treatment of Duchenne Muscular Dystrophy.

FDA Grants Orphan Drug Designation to Stealth BioTherapeutics ...

Elamipretide, which treats muscle weakness caused by mitochondrial disease, has received FDA Orphan Drug Designation.

Stealth receives orphan drug designation for elamipretide to treat DMD

Stealth BioTherapeutics has received Orphan Drug Designation from the US FDA to treat Duchenne muscular dystrophy (DMD) patients.

EU/3/21/2430 - orphan designation for treatment of Barth syndrome

This means that the developer will receive scientific and regulatory support from EMA to advance their medicine to the stage where they can ...

FDA Grants Orphan Drug Designation to Elamipretide for Bath ...

AND017 Receives FDA Orphan Drug Designation for Sickle Cell Disease | Image Credit: US Food. Credit: US Food and Drug Administration. The US ...

Elamipretide Clinical Studies and Trials - Stealth BioTherapeutics

We have received Fast Track and Orphan Drug designation from the FDA for the development of elamipretide in this indication. The U.S. Food and Drug ...