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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: gormley nj. Cancer Discov. 2023 Dec 12;13(12):2515-2524. doi: 10.1158/2159-8290.CD-23-1226. Cancer Discov. 2023. PMID: 38084090
Recombinant human factor VIIa for alveolar hemorrhage following allogeneic stem cell transplantation.
Elinoff JM, Bagci U, Moriyama B, Dreiling JL, Foster B, Gormley NJ, Salit RB, Cai R, Sun J, Beri A, Reda DJ, Fakhrejahani F, Battiwalla M, Baird K, Cuellar-Rodriguez JM, Kang EM, Pavletic SZ, Fowler DH, John Barrett A, Lozier JN, Kleiner DE Jr, Mollura DJ, Childs RW, Suffredini AF. Elinoff JM, et al. Among authors: gormley nj. Biol Blood Marrow Transplant. 2014 Jul;20(7):969-78. doi: 10.1016/j.bbmt.2014.03.015. Epub 2014 Mar 20. Biol Blood Marrow Transplant. 2014. PMID: 24657447 Free PMC article.
FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy.
Bhatnagar V, Gormley NJ, Luo L, Shen YL, Sridhara R, Subramaniam S, Shen G, Ma L, Shord S, Goldberg KB, Farrell AT, McKee AE, Pazdur R. Bhatnagar V, et al. Among authors: gormley nj. Oncologist. 2017 Nov;22(11):1347-1353. doi: 10.1634/theoncologist.2017-0229. Epub 2017 Sep 13. Oncologist. 2017. PMID: 28904172 Free PMC article. Clinical Trial.
48 results