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Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development.
Donaldson JM, Seddiq M, Fusco MJ, Singla S, Pamuk GE, Lee-Alonso RJ, Mixter BD, Goldberg KB, Amiri-Kordestani L, de Claro RA, Drezner N, Gormley NJ, Kanapuru B, Lemery SJ, Fashoyin-Aje LA, Richardson NC, Singh H, Suzman DL, Theoret MR, Kluetz PG, Pazdur R. Donaldson JM, et al. Among authors: richardson nc. Cancer Discov. 2023 Dec 12;13(12):2515-2524. doi: 10.1158/2159-8290.CD-23-1226. Cancer Discov. 2023. PMID: 38084090
Second Paediatric Strategy Forum for anaplastic lymphoma kinase (ALK) inhibition in paediatric malignancies: ACCELERATE in collaboration with the European Medicines Agency with the participation of the Food and Drug Administration.
Pearson ADJ, Barry E, Mossé YP, Ligas F, Bird N, de Rojas T, Zimmerman ZF, Wilner K, Woessmann W, Weiner S, Weigel B, Venkatramani R, Valteau D, Trahair T, Smith M, Singh S, Selvaggi G, Scobie N, Schleiermacher G, Richardson N, Park J, Nysom K, Norga K, Merino M, McDonough J, Matloub Y, Marshall LV, Lowe E, Lesa G, Irwin M, Karres D, Gajjar A, Doz F, Fox E, DuBois SG, Donoghue M, Casanova M, Caron H, Buenger V, Bradford D, Blanc P, Barone A, Reaman G, Vassal G. Pearson ADJ, et al. Among authors: richardson n. Eur J Cancer. 2021 Nov;157:198-213. doi: 10.1016/j.ejca.2021.08.022. Epub 2021 Sep 15. Eur J Cancer. 2021. PMID: 34536944 Free article. Review.
Paediatric Strategy Forum for medicinal product development of chimeric antigen receptor T-cells in children and adolescents with cancer: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Pearson AD, Rossig C, Mackall C, Shah NN, Baruchel A, Reaman G, Ricafort R, Heenen D, Bassan A, Berntgen M, Bird N, Bleickardt E, Bouchkouj N, Bross P, Brownstein C, Cohen SB, de Rojas T, Ehrlich L, Fox E, Gottschalk S, Hanssens L, Hawkins DS, Horak ID, Taylor DH, Johnson C, Karres D, Ligas F, Ludwinski D, Mamonkin M, Marshall L, Masouleh BK, Matloub Y, Maude S, McDonough J, Minard-Colin V, Norga K, Nysom K, Pappo A, Pearce L, Pieters R, Pule M, Quintás-Cardama A, Richardson N, Schüßler-Lenz M, Scobie N, Sersch MA, Smith MA, Sterba J, Tasian SK, Weigel B, Weiner SL, Zwaan CM, Lesa G, Vassal G. Pearson AD, et al. Among authors: richardson n. Eur J Cancer. 2022 Jan;160:112-133. doi: 10.1016/j.ejca.2021.10.016. Epub 2021 Nov 25. Eur J Cancer. 2022. PMID: 34840026 Free article. Review.
441 results