检索结果 - Youwei Bi
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Model-informed drug development approach supporting approval of the 4-week (Q4W) dosing schedule for nivolumab (Opdivo) across multiple indications: a regulatory perspective 由 Youwei Bi, Jun-Qiao Liu, Brian D. Furmanski, Hong Zhao, Jiajie Yu, Christy Osgood, A. Ward, Patricia Keegan, B.P. Booth, Atiqur Rahman, Y. Wang
出版 2019Artigo -
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US Food and Drug Administration Approval Summary: Nivolumab Plus Platinum-Doublet Chemotherapy for the Neoadjuvant Treatment of Patients With Resectable Non–Small-Cell Lung Cancer... 由 Oladimeji Akinboro, Nicole Drezner, Anup Amatya, Runyan Jin, Jeanne Fourie-Zirkelbach, Miao Zhao, Youwei Bi, Kwadwo Ameyaw Korsah, Bronwyn D. Mixter, Shenghui Tang, Erin Larkins, Richard Pazdur, Julia A. Beaver, Harpreet Singh
出版 2023Artigo -
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FDA Approval Summary: Sotorasib for <i>KRAS G12C</i>-Mutated Metastatic NSCLC 由 Erica C. Nakajima, Nicole Drezner, Xiaoxue Li, Pallavi S. Mishra‐Kalyani, Yajun Liu, Hong Zhao, Youwei Bi, Jiang Liu, Atiqur Rahman, Emily Wearne, Idara Ojofeitimi, Lauren Tesh Hotaki, Dianne Spillman, Richard Pazdur, Julia A. Beaver, Harpreet Singh
出版 2021Artigo -
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FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer 由 Elizabeth S. Duke, Amy Barone, Somak Chatterjee, Pallavi S. Mishra‐Kalyani, Yuan Li Shen, Emasenyie Isikwei, Hong Zhao, Youwei Bi, Jiang Liu, Nam Atiqur Rahman, Emily Wearne, John K. Leighton, Maritsa Stephenson, Idara Ojofeitimi, Barbara Scepura, Abhilasha Nair, Richard Pazdur, Julia A. Beaver, Harpreet Singh
出版 2022Artigo -
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FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With <i>RET</i> Gene Mutations or Fusions 由 Janice Kim, Diana Bradford, Erin Larkins, Lee H. Pai-Scherf, Somak Chatterjee, Pallavi S. Mishra‐Kalyani, Emily Wearne, Whitney S. Helms, Amal Ayyoub, Youwei Bi, Jielin Sun, Rosane Charlab, Jiang Liu, Hong Zhao, Dun Liang, Soma Ghosh, Reena Philip, Richard Pazdur, Marc R. Theoret, Julia A. Beaver, Harpreet Singh
出版 2021Artigo -
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FDA Approval Summary: Dabrafenib in Combination with Trametinib for <i>BRAF</i>V600E Mutation–Positive Low-Grade Glioma 由 Michael I. Barbato, Jeannette Nashed, Diana Bradford, Yi Ren, Sachia G. Khasar, Claudia P. Miller, Banu S. Zolnik, Hong Zhao, Yangbing Li, Youwei Bi, Stacy S. Shord, Anup Amatya, Pallavi S. Mishra‐Kalyani, Barbara Scepura, Raniya Ali Al-Matari, Richard Pazdur, Paul G. Kluetz, Martha Donoghue, Harpreet Singh, Nicole Drezner
出版 2023Artigo -
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FDA Approval Summary: Mobocertinib for Metastatic Non–Small Cell Lung Cancer with <i>EGFR</i> Exon 20 Insertion Mutations 由 Elizabeth S. Duke, Liza Stapleford, Nicole Drezner, Anup Amatya, Pallavi S. Mishra‐Kalyani, Yuan Li Shen, Kimberly Maxfield, Jeanne Fourie Zirkelbach, Youwei Bi, Jiang Liu, Xinyuan Zhang, Hezhen Wang, Yuching Yang, Nan Zheng, Kelie Reece, Emily Wearne, Jacqueline J. Glen, Idara Ojofeitimi, Barbara Scepura, Abhilasha Nair, Rama Kamesh Bikkavilli, Soma Ghosh, Reena Philip, Richard Pazdur, Julia A. Beaver, Harpreet Singh, Martha Donoghue
出版 2022Artigo -
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FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations 由 Luckson Mathieu, Erin Larkins, Oladimeji Akinboro, Pourab Roy, Anup Amatya, Mallorie H. Fiero, Pallavi S. Mishra‐Kalyani, Whitney S. Helms, Claire E. Myers, Amy M. Skinner, Stephanie Aungst, Runyan Jin, Hong Zhao, Huiming Xia, Jeanne Fourie Zirkelbach, Youwei Bi, Yangbing Li, Jiang Liu, Manuela Grimstein, Xinyuan Zhang, Stacie Woods, Kelie Reece, Abde M. Abukhdeir, Soma Ghosh, Reena Philip, Shenghui Tang, Kirsten B. Goldberg, Richard Pazdur, Julia A. Beaver, Harpreet Singh
出版 2021Revisão -
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FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1–High NSCLC 由 Oladimeji Akinboro, Erin Larkins, Lee H. Pai-Scherf, Luckson Mathieu, Yi Ren, Joyce Cheng, Mallorie H. Fiero, Wentao Fu, Youwei Bi, Shyam Kalavar, Samina Jafri, Pallavi S. Mishra‐Kalyani, Jeanne Fourie Zirkelbach, Hongshan Li, Hong Zhao, Kun He, Whitney S. Helms, Meredith K. Chuk, Min Wang, Ilynn Bulatao, Jonathan Herz, Blaire L. Osborn, Yuan Xu, Jiang Liu, Yutao Gong, Sharon Sickafuse, Rebecca W. Cohen, Martha Donoghue, Richard Pazdur, Julia A. Beaver, Harpreet Singh
出版 2022Artigo
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