日期:
2020 年 — 2026 年
2020
2021
2022
2023
2024
2025
2026
影响因子:

FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

FDA批准摘要:尼拉帕尼联合醋酸阿比特龙固定剂量组合用于治疗BRCA突变转移性去势抵抗性前列腺癌

Maguire, William F; Chi, Dow-Chung; Agrawal, Sundeep; Joeng, Hee-Koung; Kim-McOlash, Sarah; Manheng, Wimolnut; Bulatao, Ilynn; Sanchez-Solana, Beatriz; Pathak, Anand; Lee, Alice; Han, Yu; Ricks, Tiffany K; Hamed, Salaheldin S; Fiero, Mallorie H; Pierce, William F; Kalavar, Shyam; Ghosh, Soma; Leighton, John K; Tang, Shenghui; Amiri-Kordestani, Laleh; Kluetz, Paul G; Suzman, Daniel L

FDA Approval Summary: Tovorafenib for Relapsed or Refractory BRAF-Altered Pediatric Low-Grade Glioma

FDA批准摘要:托沃拉非尼用于治疗复发或难治性BRAF突变型儿童低级别胶质瘤

Singh, Sonia; Bradford, Diana; Chatterjee, Somak; Li, Xiaoxue; Aungst, Stephanie L; Skinner, Amy M; Miller, Claudia P; Kim-McOlash, Sarah; Fourie Zirkelbach, Jeanne; Xiong, Ye; Bi, Youwei; Wang, Ying-Hong; Yang, Yuching; Sun, Jielin; Kraft, Jeffrey; Charlab, Rosane; Shord, Stacy S; Tang, Shenghui; Scepura, Barbara; Bulatao, Ilynn; Udoka, Opeyemi; Saber, Haleh; Rahman, Nam Atiqur; Pazdur, Richard; Singh, Harpreet; Donoghue, Martha; Drezner, Nicole

Cardiac Adverse Events in Patients Receiving Immune Checkpoint Inhibitors in the Adjuvant Setting: An FDA Pooled Analysis

接受免疫检查点抑制剂辅助治疗的患者发生心脏不良事件:FDA汇总分析

Dilawari, Asma; Krantz, Mori J; Bulatao, Ilynn; Joeng, Hee-Koung; Neilson, Marc; Wedam, Suparna; Gao, Xin; Fiero, Mallorie H; Nair, Abhilasha; Theoret, Marc; Amiri-Kordestani, Laleh

US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer

美国食品药品监督管理局批准摘要:Elacestrant 用于治疗雌激素受体阳性、人表皮生长因子受体 2 阴性、ESR1 突变的晚期或转移性乳腺癌

Shah, Mirat; Lingam, Hima; Gao, Xin; Gittleman, Haley; Fiero, Mallorie H; Krol, Danielle; Biel, Nikolett; Ricks, Tiffany K; Fu, Wentao; Hamed, Salaheldin; Li, Fang; Sun, Jillian Jielin; Fan, Jianghong; Schuck, Robert; Grimstein, Manuela; Tang, Liuya; Kalavar, Shyam; Abukhdeir, Abdelrahmman; Pathak, Anand; Ghosh, Soma; Bulatao, Ilynn; Tilley, Amy; Pierce, William F; Mixter, Bronwyn D; Tang, Shenghui; Pazdur, Richard; Kluetz, Paul; Amiri-Kordestani, Laleh

The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes

上市前临床开发期间患者暴露量差异对上市后安全性结果的影响

Cherkaoui, Sanae; Pinnow, Ellen; Bulatao, Ilynn; Day, Brendan; Kalaria, Manish; Brajovic, Sonja; Dal Pan, Gerald

Postmarketing Safety-Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002-2014: Similarities and Differences With New Molecular Entities

2002-2014年美国批准的新治疗性生物制品的上市后安全性相关监管行动:与新分子实体的异同

Bulatao, Ilynn; Pinnow, Ellen; Day, Brendan; Cherkaoui, Sanae; Kalaria, Manish; Brajovic, Sonja; Dal Pan, Gerald

Functional status predicts major complications and death after endovascular repair of abdominal aortic aneurysms

功能状态可预测腹主动脉瘤腔内修复术后的主要并发症和死亡

Harris, Donald G; Bulatao, Ilynn; Oates, Connor P; Kalsi, Richa; Drucker, Charles B; Menon, Nandakumar; Flohr, Tanya R; Crawford, Robert S

Radiologic Characterization of Ischemic Cholangiopathy in Donation-After-Cardiac-Death Liver Transplants and Correlation With Clinical Outcomes

心脏死亡后捐献肝移植中缺血性胆管病的放射学特征及其与临床结果的相关性

Giesbrandt, Kirk J; Bulatao, Ilynn G; Keaveny, Andrew P; Nguyen, Justin H; Paz-Fumagalli, Ricardo; Taner, C Burcin