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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: pamuk ge. Cancer Discov. 2023 Dec 12;13(12):2515-2524. doi: 10.1158/2159-8290.CD-23-1226. Cancer Discov. 2023. PMID: 38084090
Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia.
Sweet KL, Cortes JE, Apperley JF, Mann M, Mauro MJ, Oehler VG, Ruiz C, Schiffer CA, Ehrlich LA, Pamuk GE, Wynne J, Mehta GU, de Claro RA, Theoret MR, Smith BD, Norsworthy KJ. Sweet KL, et al. Among authors: pamuk ge. Clin Cancer Res. 2023 Jun 13;29(12):2179-2183. doi: 10.1158/1078-0432.CCR-22-2628. Clin Cancer Res. 2023. PMID: 36547666 Free PMC article.
Trends in the approval of cancer therapies by the FDA in the twenty-first century.
Scott EC, Baines AC, Gong Y, Moore R Jr, Pamuk GE, Saber H, Subedee A, Thompson MD, Xiao W, Pazdur R, Rao VA, Schneider J, Beaver JA. Scott EC, et al. Among authors: pamuk ge. Nat Rev Drug Discov. 2023 Aug;22(8):625-640. doi: 10.1038/s41573-023-00723-4. Epub 2023 Jun 21. Nat Rev Drug Discov. 2023. PMID: 37344568 Review.
Project Confirm: Accelerated Drug Approvals for CML-Response.
Sweet KL, Cortes JE, Apperley JF, Mann M, Mauro MJ, Oehler VG, Ruiz C, Schiffer CA, Ehrlich LA, Pamuk GE, Wynne J, Mehta GU, Okusanya OO, de Claro RA, Theoret MR, Smith BD, Norsworthy KJ. Sweet KL, et al. Among authors: pamuk ge. Clin Cancer Res. 2024 Jan 5;30(1):237-238. doi: 10.1158/1078-0432.CCR-23-3234. Clin Cancer Res. 2024. PMID: 38178776 Free PMC article. No abstract available.
109 results