FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors von Marcus, Leigh, Lemery, Steven J, Keegan, Patricia, Pazdur, Richard

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FDA Approval Summary: Pembrolizumab for the Treatment of Tumor Mutational Burden-High Solid Tumors von Marcus, Leigh, Fashoyin-Aje, Lola A, Donoghue, Martha, Yuan, Mengdie, Rodriguez, Lisa, Gallagher, Pamela S, Philip, Reena, Ghosh, Soma, Theoret, Marc R, Beaver, Julia A, Pazdur, Richard, Lemery, Steven J

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The disturbed fracture process zone theory for the assessment of the asymptotic fracture energy of concrete von Lemery, J., Ben Ftima, M., Leclerc, M., Wang, Cong

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Managing upstream oil and gas emissions: A public health oriented approach von Calderon, J.L., Sorensen, C., Lemery, J., Workman, C.F., Linstadt, H., Bazilian, M.D.

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FDA Approval Summary: Ramucirumab for Gastric Cancer von Casak, Sandra J, Fashoyin-Aje, Ibilola, Lemery, Steven J, Zhang, Lillian, Jin, Runyan, Li, Hongshan, Zhao, Liang, Zhao, Hong, Zhang, Hui, Chen, Huanyu, He, Kun, Dougherty, Michele, Novak, Rachel, Kennett, Sarah, Khasar, Sachia, Helms, Whitney, Keegan, Patricia, Pazdur, Richard

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FDA Approval Summary: Lenvatinib for Progressive, Radio-iodine-Refractory Differentiated Thyroid Cancer von Nair, Abhilasha, Lemery, Steven J, Yang, Jun, Marathe, Anshu, Zhao, Liang, Zhao, Hong, Jiang, Xiaoping, He, Kun, Ladouceur, Gaetan, Mitra, Amit K, Zhou, Liang, Fox, Emily, Aungst, Stephanie, Helms, Whitney, Keegan, Patricia, Pazdur, Richard

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FDA Approval Summary: TAS-102 von Marcus, Leigh, Lemery, Steven J, Khasar, Sachia, Wearne, Emily, Helms, Whitney S, Yuan, Weishi, He, Kun, Cao, Xianhua, Yu, Jingyu, Zhao, Hong, Wang, Yaning, Stephens, Olen, Englund, Erika, Agarwal, Rajiv, Keegan, Patricia, Pazdur, Richard

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FDA's Approval of the First  Biosimilar to Bevacizumab von Casak, Sandra J, Lemery, Steven J, Chung, Jee, Fuchs, Chana, Schrieber, Sarah J, Chow, Edwin C Y, Yuan, Weishi, Rodriguez, Lisa, Gwise, Thomas, Rowzee, Anne, Lim, Sue, Keegan, Patricia, McKee, Amy E, Pazdur, Richard

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Associations Between Dust Storms and Intensive Care Unit Admissions in the United States, 2000–2015 von Rublee, C. S., Sorensen, C. J., Lemery, J., Wade, T. J., Sams, E. A., Hilborn, E. D., Crooks, J. L.

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FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma von Casak, Sandra J, Donoghue, Martha, Fashoyin-Aje, Lola, Jiang, Xiaoping, Rodriguez, Lisa, Shen, Yuan-Li, Xu, Yuan, Jiang, Xiling, Liu, Jiang, Zhao, Hong, Pierce, William F, Mehta, Shubhangi, Goldberg, Kirsten B, Theoret, Marc R, Kluetz, Paul G, Pazdur, Richard, Lemery, Steven J

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FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma von Casak, Sandra J, Marcus, Leigh, Fashoyin-Aje, Lola, Mushti, Sirisha L, Cheng, Joyce, Shen, Yuan-Li, Pierce, William F, Her, Leah, Goldberg, Kirsten B, Theoret, Marc R, Kluetz, Paul G, Pazdur, Richard, Lemery, Steven J

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Tissue-Agnostic Drug Development: A New Path to Drug Approval von Thein, Kyaw Z, Lemery, Steven J, Kummar, Shivaani

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Technology modification, development, and demonstrations for future spaceflight medical systems at NASA von Lewandowski, B. E., Schkurko, C. M., Miller, R. S., Valentine, R. W., Calaway, K. M., Yang, J. D., Ebert, D. J., Sargsyan, A., Byrne, V., Walton, M., Lemery, J., Suresh, R., Thompson, M. S., Easter, B. D., Lehnhardt, K. R.

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FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation von Casak, Sandra J, Pradhan, Shan, Fashoyin-Aje, Lola A, Ren, Yi, Shen, Yuan-Li, Xu, Yuan, Chow, Edwin Chiu Yuen, Xiong, Ye, Zirklelbach, Jeanne Fourie, Liu, Jiang, Charlab, Rosane, Pierce, William F, Fesenko, Nataliya, Beaver, Julia A, Pazdur, Richard, Kluetz, Paul G, Lemery, Steven J

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FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer von Casak, Sandra J, Horiba, M Naomi, Yuan, Mengdie, Cheng, Joyce, Lemery, Steven J, Shen, Yuan Li, Fu, Wentao, Moore, Jason N, Li, Yangbing, Bi, Youwei, Auth, Doris, Fesenko, Nataliya, Kluetz, Paul G, Pazdur, Richard, Fashoyin-Aje, Lola A

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FDA Approval Summary: Selpercatinib for the treatment of advanced RET fusion-positive solid tumors von Duke, Elizabeth S, Bradford, Diana, Marcovitz, Michelle, Amatya, Anup K, Mishra-Kalyani, Pallavi S, Nguyen, Emily, Price, Lauren S L, Fourie Zirkelbach, Jeanne, Li, Yangbing, Bi, Youwei, Kraft, Jeffrey, Dorff, Sarah E, Scepura, Barbara, Stephenson, Maritsa, Ojofeitimi, Idara, Nair, Abhilasha, Han, Yu, Tezak, Zivana, Lemery, Steven J, Pazdur, Richard, Larkins, Erin, Singh, Harpreet

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Asymptotic fracture energy for nonlinear simulation of mass concrete structures von Ben Ftima, M., Lemery, J.

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FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement von Patel, Timil H, Marcus, Leigh, Horiba, M Naomi, Donoghue, Martha, Chatterjee, Somak, Mishra-Kalyani, Pallavi S, Schuck, Robert N, Li, Yangbing, Zhang, Xinyuan, Fourie Zirkelbach, Jeanne, Charlab, Rosane, Liu, Jiang, Yang, Yuching, Lemery, Steven J, Pazdur, Richard, Theoret, Marc R, Fashoyin-Aje, Lola A

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FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements von Gandhy, Shruti U, Casak, Sandra J, Mushti, Sirisha L, Cheng, Joyce, Subramaniam, Sriram, Zhao, Hong, Zhao, Miao, Bi, Youwei, Liu, Guansheng, Fan, Jianghong, Adeniyi, Oluseyi, Charlab, Rosane, Kufrin, Dubravka, Thompson, Matthew D, Jarrell, Kristin, Auth, Doris, Lemery, Steven J, Pazdur, Richard, Kluetz, Paul G, Fashoyin-Aje, Lola A

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FDA Approval Summary: Nivolumab for the Adjuvant Treatment of Adults with Completely Resected Esophageal/Gastroesophageal Junction Cancer and Residual Pathologic Disease von Horiba, M Naomi, Casak, Sandra J, Mishra-Kalyani, Pallavi S, Roy, Pourab, Beaver, Julia A, Pazdur, Richard, Kluetz, Paul G, Lemery, Steven J, Fashoyin-Aje, Lola A

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