The waiting time for Latin American patients with cancer, central nervous system disorders or rare diseases can take up to ...

Applied Therapeutics stock plummets 77% after the FDA issues a CRL for the company's NDA seeking approval for govorestat to treat classic galactosemia.

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for ...

Applied Therapeutics faces challenges after FDA rejection, but future opportunities exist. Learn why APLT stock could recover ...

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The sell-off started last night and continued in after-hours trading after the New York-based biopharma company revealed that ...

Applied Therapeutics (APLT) announced the FDA has issued a Complete Response Letter for the New Drug Application for govorestat, for ...

，周三，Applied Therapeutics(APLT.US)盘后暴跌78%，报1.89美元。消息面上，美国FDA已 ，周三，Applied Therapeutics(APLT.US)盘后暴跌78%，报1.89美元。消息面上，美国FDA已拒绝批准该公司用于治疗罕见代谢疾病经典半乳糖血症的govorestat。在一封完整的回应信中，FDA表示，由于申请中存在缺陷，它无法批准该药物。 该公司表示， ...

Applied Therapeutics (APLT) announced that the FDA has issued a Complete Response Letter – CRL – for the New Drug Application – NDA – for ...

消息面上，美国FDA已拒绝批准该公司用于治疗罕见代谢疾病经典半乳糖血症的govorestat。在一封完整的回应信中，FDA表示，由于申请中存在缺陷，它无法批准该药物。该公司表示，正在审查FDA的意见，并将要求与该机构举行会议，讨论可能重新提交的必要条 ...

An FDA complete response letter indicates that an application can't be approved in its current form. Govorestat, the company's lead drug candidate, is also being developed for treatment of sorbitol ...

The FDA rejected Applied Therapeutics’ experimental treatment, govorestat, for a rare disease called classic galactosemia, ...