Elamipretide NDA 获得优先审查,PDUFA行动日期为2025 年 1 月 29 日。 Stealth BioTherapeutics Inc.(“公司”或“Stealth”)是一家临床阶段生物技术公司,专注于发现、开发和商业化治疗线粒体功能障碍疾病的新疗法,宣布美国食品和药物管理局(“FDA”)心血管和肾脏药物咨询委员会(“CRDAC”)以 10 票对 6 票通过...
Stealth BioTherapeutics Inc.(“公司”或“Stealth”)是一家临床阶段生物技术公司,专注于发现、开发和商业化治疗线粒体功能障碍疾病的新疗法,宣布美国食品和药物管理局(“FDA”)心血管和肾脏药物咨询委员会(“CRDAC”)以 10 票对 6 票通过了 Stealth 的新药申请(“NDA”),结论是 elamipretide 对治疗 Barth ...
Elamipretide is an investigational drug pending FDA approval. There is no information available on contraindications, warnings and precautions for the use of elamipretide. Common side effects of elamipretide include: painor swelling, or seeing halos around lights. This is not a complete list of ...
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FDA 专家组支持批准 Stealth 的 elamipretide 咨询委员会以 10 比 6 票通过了该决议,认定 Elamipretide 对治疗 Barth 综合征有效。Elamipretide NDA 获得优先审查,PDUFA 行动日期为2025 年 1 月 29 日。 Stealth BioTherapeutics Inc.(“公司”或“Stealth”)是一家临床阶段生物技术公司,专注于发现、开发和商业...
"We are pleased that the FDA has recognized the high unmet need for innovative treatments for DMD," said Chief Executive Officer Reenie McCarthy. "We look forward to further discussions with the FDA regarding our development initiativ...
FDA, the EMA or other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, which may affect the initiation, timing and progress of preclinical studies and clinical trials of Stealth BioTherapeutics product candidates; Steal...
LHON is an inherited mitochondrial disease that causes loss of central vision due to damage to neurons in the retina, called retinal ganglion cells. The disease, which affects approximately 10,000 people in the United States, can lead to legal blindness, and there are ...
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. About Barth Syndrome Barth syndrome is an ultra-rare genetic...
The FDA has also given the therapy a fast track designation aimed at accelerating its approval. *** Mitochondrial Disease News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended t...