Belite Bio 宣布:美国FDA已受理Tinlarebant治疗1型Stargardt病的新药申请并授予优先审评资格

美股速递
Aug 12

Belite Bio, Inc. 今日正式对外发布公告,称美国食品药品监督管理局(FDA)已正式受理其针对1型Stargardt病(一种遗传性视网膜病变)的治疗药物Tinlarebant所提交的新药申请(NDA)。更令人瞩目的是,该申请同时被授予了优先审评资格。这一决定标志着该药物在通往获批上市的道路上迈出了至关重要的一步,为饱受此类罕见眼疾困扰的患者群体带来了新的希望。

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