Approval Summary: Azacitidine for Treatment of Myelodysplastic Syndrome Subtypes
KAMINSKAS, Edvardas, FARRELL, Ann, WANG, Yong-Cheng, PAZDUR, Richard, ABRAHAM, Sophia, BAIRD, Amy, HSIEH, Li-Shan, LEE, Shwu-Luan, LEIGHTON, John K, PATEL, Hasmukh, RAHMAN, Atiqur, SRIDHARA, Rajeshwara
Published in Clinical cancer research (15.05.2005)
Published in Clinical cancer research (15.05.2005)
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Tasigna for Chronic and Accelerated Phase Philadelphia Chromosome–Positive Chronic Myelogenous Leukemia Resistant to or Intolerant of Imatinib
HAZARIKA, Maitreyee, XIAOPING JIANG, TIMMER, William, HARAPANHALLI, Ravi, DAGHER, Ramzi, JUSTICE, Robert, PAZDUR, Richard, QI LIU, LEE, Shwu-Luan, RAMCHANDANI, Roshni, GARNETT, Christine, ORR, Micheal S, SRIDHARA, Rajeshwari, BOOTH, Brian, LEIGHTON, John K
Published in Clinical cancer research (01.09.2008)
Published in Clinical cancer research (01.09.2008)
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FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer
Duke, Elizabeth S, Barone, Amy K, Chatterjee, Somak, Mishra-Kalyani, Pallavi S, Shen, Yuan-Li, Isikwei, Emasenyie, Zhao, Hong, Bi, Youwei, Liu, Jiang, Rahman, Nam Atiqur, Wearne, Emily, Leighton, John K, Stephenson, Maritsa, Ojofeitimi, Idara, Scepura, Barbara, Nair, Abhilasha, Pazdur, Richard, Beaver, Julia A, Singh, Harpreet
Published in Clinical cancer research (03.10.2022)
Published in Clinical cancer research (03.10.2022)
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An FDA oncology analysis of CD3 bispecific constructs and first-in-human dose selection
Saber, Haleh, Del Valle, Pedro, Ricks, Tiffany K., Leighton, John K.
Published in Regulatory toxicology and pharmacology (01.11.2017)
Published in Regulatory toxicology and pharmacology (01.11.2017)
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FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer
Royce, Melanie, Osgood, Christy L, Amatya, Anup K, Fiero, Mallorie H, Chang, C J George, Ricks, Tiffany K, Shetty, Krithika A, Kraft, Jeffrey, Qiu, Junshan, Song, Pengfei, Charlab, Rosane, Yu, Jingyu, King, Kathryn E, Rastogi, Anshu, Janelsins, Brian, Weinberg, Wendy C, Clouse, Kathleen, Borders-Hemphill, Vicky, Brown, Lindsey, Gomez-Broughton, Candace, Li, Zhong, Nguyen, Thuy Thanh, Qiu, Zhihao, Ly, Anh-Thy, Chang, Suyoung, Gao, Tingting, Tu, Chi-Ming, King-Kallimanis, Bellinda, Pierce, William F, Chiang, Kelly, Lee, Clara, Goldberg, Kirsten B, Leighton, John K, Tang, Shenghui, Pazdur, Richard, Beaver, Julia A, Amiri-Kordestani, Laleh
Published in Clinical cancer research (14.04.2022)
Published in Clinical cancer research (14.04.2022)
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FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non–Small Cell Lung Cancer
Barbato, Michael I., Bradford, Diana, Ren, Yi, Aungst, Stephanie L., Miller, Claudia P., Pan, Lili, Zirkelbach, Jeanne F., Li, Yangbing, Bi, Youwei, Fan, Jianghong, Grimstein, Manuela, Dorff, Sarah E., Amatya, Anup K., Mishra-Kalyani, Pallavi S., Scepura, Barbara, Schotland, Peter, Udoka, Opeyemi, Ojofeitimi, Idara, Leighton, John K., Rahman, Nam A., Pazdur, Richard, Singh, Harpreet, Kluetz, Paul G., Drezner, Nicole
Published in Clinical cancer research (15.08.2024)
Published in Clinical cancer research (15.08.2024)
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An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products
Manning, Michael L., Thompson, Matthew D., Saber, Haleh, Maher, Virginia E., Crich, Joyce Z., Leighton, John K.
Published in Regulatory toxicology and pharmacology (01.02.2020)
Published in Regulatory toxicology and pharmacology (01.02.2020)
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Pharmacogenomic data submissions to the FDA: non-clinical case studies
Leighton, John K, DeGeorge, Joseph, Jacobson-Kram, David, MacGregor, James, Mendrick, Donna, Worobec, Alexandra
Published in Pharmacogenomics (01.07.2004)
Published in Pharmacogenomics (01.07.2004)
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Conference Proceeding
Workgroup Report: Review of Genomics Data Based on Experience with Mock Submissions: View of the CDER Pharmacology Toxicology Nonclinical Pharmacogenomics Subcommittee
Leighton, John K., Brown, Paul, Ellis, Amy, Harlow, Patricia, Harrouk, Wafa, Pine, P. Scott, Robison, Timothy, Rosario, Lilliam, Thompson, Karol
Published in Environmental health perspectives (01.04.2006)
Published in Environmental health perspectives (01.04.2006)
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NTP monograph on the systematic review of occupational exposure to cancer chemotherapy agents and adverse health outcomes
Published in NTP monograph
(01.03.2019)
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Isolation and sequence analysis of three cloned cDNAs for rabbit liver proteins that are related to rabbit cytochrome P-450 (form 2), the major phenobarbital-inducible form
Leighton, John K, DeBrunner-Vossbrinck, Bettina A, Kemper, Byron
Published in Biochemistry (Easton) (1984)
Published in Biochemistry (Easton) (1984)
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Pharmacogenomic data submissions to the FDA: non-clinical case studies
Leighton, John K, DeGeorge, Joseph, Jacobson-Kram, David, MacGregor, James, Mendrick, Donna, Worobec, Alexandra
Published in Pharmacogenomics (01.07.2004)
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Published in Pharmacogenomics (01.07.2004)
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