Velcade®: U.S. FDA Approval for the Treatment of Multiple Myeloma Progressing on Prior Therapy von Kane, Robert C., Bross, Peter F., Farrell, Ann T., Pazdur, Richard

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Approval summary for bortezomib for injection in the treatment of multiple myeloma von BROSS, Peter F, KANE, Robert, LEIGHTON, John, CHENG YI LIANG, LOSTRITTO, Richard T, MCGUINN, William D, MORSE, David E, RAHMAN, Atiqur, ROSARIO, Lilliam A, VERBOIS, S. Leigh, WILLIAMS, Grant, WANG, Yong-Cheng, FARRELL, Ann T, PAZDUR, Richard, ABRAHAM, Sophia, BENSON, Kimberly, BROWER, Margaret E, BRADLEY, Sean, GOBBURU, Jogarao V, GOHEER, Anwar, LEE, Shwu-Luan

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Regulation of biologic oncology products in the FDA׳s Center for Biologics Evaluation and Research von Bross, Peter F., M.D, Fan, Chaohong, M.D, George, Bindu, M.D, Shannon, Kevin, M.D, Joshi, Bharat H., Ph.D, Puri, Raj K., M.D., Ph.D

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Approval summary: Gemtuzumab ozogamicin in relapsed acute myeloid leukemia von BROSS, Peter F, BEITZ, Julie, PAZDUR, Richard, GANG CHEN, XIAO HONG CHEN, DUFFY, Eric, KIEFFER, Lydia, ROY, Sandip, SRIDHARA, Rajeshwari, RAHMAN, Atiqur, WILLIAMS, Grant

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Fulvestrant in Postmenopausal Women with Advanced Breast Cancer von BROSS, Peter F, BAIRD, Amy, WILLIAMS, Grant, PAZDUR, Richard, GANG CHEN, JEE, Josephine M, LOSTRITTO, Richard T, MORSE, David E, ROSARIO, Liliam A, WILLIAMS, Gene M, YANG, Peiling, RAHMAN, Atiqur

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Regulation of immunotherapeutic products for cancer and FDA's role in product development and clinical evaluation von Vatsan, Ramjay S, Bross, Peter F, Liu, Ke, Theoret, Marc, De Claro, Angelo R, Lu, Jinhua, Helms, Whitney, Niland, Brian, Husain, Syed R, Puri, Raj K

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FDA Drug Approval Summaries: Fulvestrant von Bross, Peter F., Cohen, Martin H., Williams, Grant A., Pazdur, Richard

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Expanded access for cancer patients: The 5-year FDA CBER experience von Colbert, Laronna S., Bross, Peter F., Liu, Ke

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Approval Summary von Peter F. Bross, Julie Beitz, Gang Chen, Xiao Hong Chen, Eric Duffy, Lydia Kieffer, Sandip Roy, Rajeshwari Sridhara, Atiqur Rahman, Grant Williams, Richard Pazdur

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An inventory of interactors of the human HSP60/HSP10 chaperonin in the mitochondrial matrix space von Bie, Anne Sigaard, Cömert, Cagla, Körner, Roman, Corydon, Thomas J., Palmfeldt, Johan, Hipp, Mark S., Hartl, F. Ulrich, Bross, Peter

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HSP60 chaperone deficiency disrupts the mitochondrial matrix proteome and dysregulates cholesterol synthesis von Cömert, Cagla, Kjær-Sørensen, Kasper, Hansen, Jakob, Carlsen, Jasper, Just, Jesper, Meaney, Brandon F., Østergaard, Elsebet, Luo, Yonglun, Oxvig, Claus, Schmidt-Laursen, Lisbeth, Palmfeldt, Johan, Fernandez-Guerra, Paula, Bross, Peter

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Molecular mechanisms of riboflavin responsiveness in patients with ETF-QO variations and multiple acyl-CoA dehydrogenation deficiency von CORNELIUS, Nanna, FRERMAN, Frank E, CORYDON, Thomas J, PALMFELDT, Johan, BROSS, Peter, GREGERSEN, Niels, OLSEN, Rikke K. J

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APD-Containing Cyclolipodepsipeptides Target Mitochondrial Function in Hypoxic Cancer Cells von Jacobsen, Kristian Mark, Villadsen, Nikolaj Lilholm, Tørring, Thomas, Nielsen, Camilla Bak, Salomón, Trine, Nielsen, Morten Muhlig, Tsakos, Michail, Sibbersen, Christian, Scavenius, Carsten, Nielsen, Rikke, Christensen, Erik Ilsø, Guerra, Paula Fernandez, Bross, Peter, Pedersen, Jakob Skou, Enghild, Jan Johannes, Johannsen, Mogens, Frøkiær, Jørgen, Overgaard, Jens, Horsman, Michael R., Busk, Morten, Poulsen, Thomas B.

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CLPB Variants Associated with Autosomal-Recessive Mitochondrial Disorder with Cataract, Neutropenia, Epilepsy, and Methylglutaconic Aciduria von Saunders, Carol, Smith, Laurie, Wibrand, Flemming, Ravn, Kirstine, Bross, Peter, Thiffault, Isabelle, Christensen, Mette, Atherton, Andrea, Farrow, Emily, Miller, Neil, Kingsmore, Stephen F., Ostergaard, Elsebet

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In Children With Nonalcoholic Fatty Liver Disease, Zone 1 Steatosis Is Associated With Advanced Fibrosis von Africa, Jonathan A, Behling, Cynthia A, Brunt, Elizabeth M, Zhang, Nan, Luo, Yunjun, Wells, Alan, Hou, Jiayi, Belt, Patricia H, Kohil, Rohit, Lavine, Joel E, Molleston, Jean P, Newton, Kimberly P, Whitington, Peter F, Schwimmer, Jeffrey B

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Longitudinal assessment of high blood pressure in children with nonalcoholic fatty liver disease von Schwimmer, Jeffrey B, Zepeda, Anne, Newton, Kimberly P, Xanthakos, Stavra A, Behling, Cynthia, Hallinan, Erin K, Donithan, Michele, Tonascia, James

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Clear relationship between ETF/ETFDH genotype and phenotype in patients with multiple acyl-CoA dehydrogenation deficiency von Olsen, Rikke K.J., Andresen, Brage S., Christensen, Ernst, Bross, Peter, Skovby, Flemming, Gregersen, Niels

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Medium-Chain Acyl-CoA Dehydrogenase (MCAD) Mutations Identified by MS/MS-Based Prospective Screening of Newborns Differ from Those Observed in Patients with Clinical Symptoms: Iden... von Andresen, Brage Storstein, Dobrowolski, Steve F., O'Reilly, Linda, Muenzer, Joseph, McCandless, Shawn E., Frazier, Dianne M., Udvari, Szabolcs, Bross, Peter, Knudsen, Inga, Banas, Rick, Chace, Donald H., Engel, Paul, Naylor, Edwin W., Gregersen, Niels

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Pioglitazone and rofecoxib combined with angiostatically scheduled trofosfamide in the treatment of far‐advanced melanoma and soft tissue sarcoma von Reichle, Albrecht, Bross, Klaus, Vogt, Thomas, Bataille, Frauke, Wild, Peter, Berand, Anna, Krause, Stefan W., Andreesen, Reinhard

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A recurrent de novo HSPD1 variant is associated with hypomyelinating leukodystrophy von Cömert, Cagla, Brick, Lauren, Ang, Debbie, Palmfeldt, Johan, Meaney, Brandon F., Kozenko, Mariya, Georgopoulos, Costa, Fernandez-Guerra, Paula, Bross, Peter

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