XiaoMi-AI文件搜索系统
World File Search Systemindication
214662orig1s000 -AccessData.fda.gov
类别申请信息申请类型NDA申请编号214662优先级或标准优先级提交日期1/29/2021收到的日期1/29/2021 PDUFA目标日期9/29/2021 2021分司/办公室/办公室肝病学和营养（DHN）审查日期（DHN）审查日期9/23/20221223/20221 ARMAT ARMITATIRE（MARRAT） Livmarli药理学类肠胃胆酸转运蛋白（IBAT）抑制剂代码名称胆固性肝疾病（即，原发性胆道肝硬化和原发性硬化性胆管炎）（7060106）（7060106）Dosage form(s)/formulation(s) Liquid formulation Dosing regimen 380 mcg/kg/day Applicant proposed indication(s)/ population(s) Treatment of cholestatic pruritus in patients with Alagille syndrome 1 year of age and older Proposed SNOMED indication Alagille syndrome (code 31742004 arteriohepatic dysplasia disorder) Regulatory action Approval Approved dosage （如果适用）请参见上述剂量方案批准的指示（如果适用）（如果适用），请参见上述指示（s）/人群批准的指示术语（如果适用）
KPI定义和支持证据可能会发生变化。
Supporting evidence: - Description of product or process with specified performance characteristics/ physical parameters/ functionalities demonstrating novelty (new or significant improvement) of the product/process - Declaration demonstrating link with a specific KIC KAVA (indication of the specific output of KIC KAVA(s)) and financial proof of the KAVA investment in the innovation development - Documented proof such as an invoice or an online sales record demonstrating that the purchases totaling to at least客户已经制造了10k€。
215014orig1s000 -AccessData.fda.gov
表1。管理申请信息类别申请信息申请申请编号NDA 215014优先级或标准优先级提交日期9/14/2020收到的日期（S）9/14/2020 PDUFA目标日期5/14/2021 20121年10月14/2021分区/办公室司令部分区非马拉特省诉讼（DNH）审查NAMATINAME NAMENANG NAMENINE pEETANT ANDEAMEN NAPEN ANDATEN ANDATIEN EXTURN ANDATIENT/PE） proprietary name Empaveli Pharmacologic class Complement inhibitor Code name N/A Applicant Apellis Pharmaceuticals Dosage form(s)/formulation(s) Solution for infusion Dosing regimen Subcutaneous twice weekly Applicant proposed Treatment of adult patients with paroxysmal nocturnal indication(s)/ population(s) hemoglobinuria Proposed SNOMED indication Paroxysmal nocturnal血红蛋白尿液疾病调节行动批准批准剂量1080 mg/20 ml（54 mg/ml）（如果适用）批准的指示（S）/对成年型夜间夜间夜间夜间人群（如果适用）的治疗（如果适用），可点击或在此处使用文本。指示（如果适用）缩写：NDA，新药应用； PDUFA，处方药用户费用法案；呼吸，系统的医学命名法
计算机科学中的硕士论文
Deal Type: Licensing Agreement Licensor: Foreseen Biotechnology Licensee: Ipsen Biopharmaceuticals Potential Total Deal Value: USD 1bn + Royalties Asset: FS001 (Preclinical) Disease Indication: Solid Tumours Catabolism: Cleavable Payload: Topoisomerase I Inhibitor FS001 targets a novel antigen, which is overexpressed in many solid tumours and plays a critical role在增殖和转移中。该目标已识别为翻译蛋白质组学，并且AI驱动的筛选平台没有当前披露的进一步信息
2024年6月20日批准信-Everidys
2024年6月20日Sarepta Therapeutics，Inc。Attention: Patrick O'Malley 215 First Street Cambridge, MA 02142 Dear Patrick O'Malley: We have approved your request received December 21, 2023, to supplement your Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act (PHS Act) for delandistrogene moxeparvovec-rokl to expand the approved indication to individuals at least 4 years of age for the treatment of卧床患者的Duchenne肌肉营养不良（DMD），并在DMD基因中确认突变。We have also approved your request to supplement your BLA submitted under section 351(a) of the PHS Act for delandistrogene moxeparvovec-rokl to expand the approved indication to individuals at least 4 years of age for the treatment of DMD in patients who are non-ambulatory and have a confirmed mutation in the DMD gene, according to the regulations for accelerated approval, 21 CFR 601.41.基于Elevidys Micro-Dystrophin的表达，非门诊患者的DMD指示得到了加速批准。对该补充的审查与以下国家临床试验（NCT）数字有关：NCT05096221和NCT04626674。此批准要求您进一步研究生物产品，以验证和描述其临床益处，而在替代终点与临床益处的关系或观察到的临床益处与最终结果的临床益处存在不确定性。ACCELERATED APPROVAL REQUIREMENTS Under accelerated approval regulations statutory provisions and we may grant marketing approval for a biological product on the basis of adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical终点除了生存或不可逆转的发病率。
2024白皮书 - 通讯声明
Data from communication workshops held at the 2023 World Geothermal Congress and 2023 Geo- thermal Rising Conference provide a clear indication that participants would like to see increased alig- nment among geothermal associations, including coordinating membership and conferences, standar- dizing vocabulary across technologies and regions, and taking the lead in communicating the benefits of geothermal to the public and other stakeholders.他们希望地热公司和协会专注于发展该行业，而不是彼此组合。他们认为，消息传递应强调地热的可靠，稳定和可持续性的性质，重点是展示通过地球能量实现的正常日常活动。，他们希望反驳地热的想法，即某种程度上是危险的，对环境造成了破坏，或者太昂贵了。
lynparza（olaparib）
Date Action January 2015 Addition to PA March 2015 Annual review and reference update June 2016 Annual editorial review and reference update Policy change from 5.04.52 to 5.21.52 June 2017 Annual editorial review and reference update Addition of unacceptable toxicity to renewal section September 2017 Annual review Addition of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer Addition of quantity limits Removal of no concurrent therapy with other治疗卵巢癌的药物2018年2月将转移性乳腺癌添加到启动和更新标准中。在新辅助，佐剂或转移性环境中添加BRCA阳性，先前的化学疗法治疗，如果先前必须对先前的内分泌治疗进行治疗，或者必须接受内分泌治疗的治疗，或者被认为是内分泌治疗的不适当候选者，用于内部分泌治疗，用于逐年诊断为672诊断672的培养基，以诊断为672的培训标准。新指示的添加：BRCA的晚期上皮卵巢，输卵管或原发性腹膜癌。Removal of Lynparza 50mg capsules March 2019 Annual review May 2019 Changed quantity limit to 360 tablets per 90 days for both strengths of Lynparza June 2019 Annual review January 2020 Addition of indication: metastatic pancreatic cancer March 2020 Annual review May 2020 Addition of indication: used in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube或原发性腹膜癌对一线铂化学疗法有完全或部分反应，其癌症为
附件'新药清单（R-DNA起源）批准为...
09-06-2016 IMP-88/2016 Nivolumab非小细胞肺癌（NSCLC）：•Nivolumab作为单个药物被指示用于治疗局部晚期或转移性非小细胞肺癌（NSCLC）后的治疗（NSCLC）先前的化学疗法后（批准了09.09.09.09.06.06.06.2016.2016）。Nivolumab与ipilimumab结合使用，用于对成年患者的转移性非小细胞肺癌（NSCLC）的一线治疗，其肿瘤表达PD-L1（≥1％）通过经过验证的测试确定，没有EGFR或Alk基因组肿瘤差异（额外的INDICECTIC ON INDACITIC on 0.09.09.09.09.09.04.202）。 Nivolumab, in combination with ipilimumab and 2 cycles of platinum- doublet chemotherapy, is indicated for the first- line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations (additional indication approved on 09.04.2021) 2) Renal cell carcinoma (RCC):
计算机化病历系统 (CPRS) 用户指南
· 订购复杂门诊用药增加了适应症步骤 · 订购连续门诊输液订单捕获和适应症 · 订购连续门诊输液订单步骤以适应症 · 订购间歇门诊输液捕获和适应症 · 订购间歇门诊输液增加了适应症步骤 · 订购门诊用药简单剂量捕获和适应症 · 订购门诊用药简单剂量增加了适应症步骤 · 订购门诊用药复杂剂量增加了适应症捕获 · 订购门诊用药复杂剂量增加了适应症步骤 · 适应症添加到记录非 VA 药物 · 连续输液订单捕获和适应症 · 连续输液订单步骤以适应症 · 间歇输液订单捕获和适应症 · 间歇输液订单捕获和适应症
brukinsa®（zanubrutinib）胶囊，用于口服使用
- – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – brukinsa是一种激酶抑制剂，该激酶抑制剂指示用于治疗至少接受过一种先前治疗的成年患者：•地幔细胞淋巴瘤（MCL）。（1.1）根据总体响应率加速批准，此指示被批准。在验证性试验中，持续批准了此指示可能取决于对临床益处的验证和描述。•Waldenström的大球蛋白血症（WM）。（1.2）•重新或难治性边缘区淋巴瘤（MZL），他们至少接受了一种基于抗CD20的治疗方案。（1.3）根据总体响应率加速批准，此指示被批准。在验证性试验中，持续批准了此指示可能取决于对临床益处的验证和描述。•慢性淋巴细胞性白血病（CLL）或小淋巴细胞淋巴瘤（SLL）。（1.4）•在两种或更多的全身治疗线后，复发或难治性卵泡淋巴瘤（FL）与Obinutuzumab结合使用。（1.5）此指示根据响应率和响应持续性得到加速批准批准。在验证性试验中，持续批准了此指示可能取决于对临床益处的验证和描述。