Praxis Precision Medicines, Inc.(以下简称"Praxis")今日宣布,其研发药物盐酸乌利沙卡酰胺(Ulixacaltamide Hcl)已获得美国食品药品监督管理局(FDA)授予的突破性疗法认定,适应症为原发性震颤。
该认定基于临床数据表明该药物相较于现有疗法可能展现出显著优势。突破性疗法资格将加速药物研发与审评进程,为患者提供更早获得创新治疗的机会。
Praxis Precision Medicines, Inc.(以下简称"Praxis")今日宣布,其研发药物盐酸乌利沙卡酰胺(Ulixacaltamide Hcl)已获得美国食品药品监督管理局(FDA)授予的突破性疗法认定,适应症为原发性震颤。
该认定基于临床数据表明该药物相较于现有疗法可能展现出显著优势。突破性疗法资格将加速药物研发与审评进程,为患者提供更早获得创新治疗的机会。
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