Applied Therapeutics因药物研究面临FDA审查
据该公司称,FDA的检查产生了某些观察结果,Applied Therapeutics已经做出回应,并认为已解决任何未决问题。公司表示,所提到的给药错误导致少数患者的药物水平略低于目标水平,但在维持剂量阶段之前已得到纠正。Applied Therapeutics坚持认为,所有必要的详细记录都按照FDA规定保存,并已提供给该机构。
Applied Therapeutics says it received FDA's warning letter for genetic disease drug study
Applied Therapeutics said on Monday it received a warning letter limited to a trial studying its genetic disease drug, after ...
BioSpace1 天
Applied Therapeutics Crashes After FDA Rejection of Rare Disease Drug
After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ ...
Applied Therapeutics Stock Plummets 73%. The FDA Delivers This Crushing Blow.
The pharma company's shares are getting crushed after regulators decline to green light a drug to treat a rare disease.
Optimistic Outlook for Applied Therapeutics Despite FDA Setback
Leerink Partners analyst Joseph Schwartz has maintained their bullish stance on APLT stock, giving a Buy rating on November 29.Don't Miss our ...
美股异动 | FDA完整回应信中拒绝批准药物 Applied Therapeutics(APLT.US)盘后 ...
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 ...
Applied Therapeutics Stock Plummets After FDA Rejects Metabolic Disease Drug
Applied Therapeutics' New Drug Application for a rare metabolic disease was rejected by the Food and Drug Administration, ...
FierceBiotech1 天
FDA rejects Applied filing for rare disease approval on clinical grounds, sinking stock
The FDA has rejected Applied Therapeutics’ attempt to win approval on the strength of a failed phase 3 trial, triggering a 75 ...
BioPharma Dive1 天
Applied’s rare disease drug rejected by FDA
Executives at Applied Therapeutics told analysts they were surprised by the agency’s refusal to approve the company’s ...
腾讯网4 天
美股异动 | Applied Therapeutics(APLT.US)开盘重挫76% 创纪录跌幅
智通财经APP获悉，周五，Applied Therapeutics ...
Applied Therapeutics: FDA Denial Of Govorestat NDA As Problematic As It Was Unexpected
Applied Therapeutics faces challenges after FDA rejection, but future opportunities exist. Learn why APLT stock could recover ...
FDA拒绝批准Applied Therapeutics公司的半乳糖血症药物
纽约 - 生物制药公司Applied Therapeutics Inc. (NASDAQ:APLT)收到了美国食品和药物管理局 (FDA)关于其新药申请 (NDA)的完整回复函 (CRL)。该公司的govorestat治疗药物旨在治疗经典半乳糖血症,这是一种罕见的代谢疾病,但由于临床应用缺陷,该药物未能以其当前形式获得批准。