Výsledky vyhledávání

Akademický článek

FDA Approval Summary: Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Carcinoma.

Autor: Chang E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. elaine.chang@fda.hhs.gov., Weinstock C; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zhang L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Charlab R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Dorff SE; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Gong Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Hsu V; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Li F; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ricks TK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Song P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Waldron PE; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Yu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zahalka E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Goldberg KB; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Theoret MR; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Ibrahim A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Beaver JA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Publikováno v: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2021 Feb 15; Vol. 27 (4), pp. 922-927. Date of Electronic Publication: 2020 Sep 22.

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Review

BCR-ABL1 tyrosine kinase inhibitor-associated thyroid dysfunction: A review of cases reported to the FDA Adverse Event Reporting System and published in the literature.

Autor: Patel S; Division of Pharmacovigilance, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration, Silver Spring, Maryland., Nayernama A; Division of Pharmacovigilance, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration, Silver Spring, Maryland., Jones SC; Division of Pharmacovigilance, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration, Silver Spring, Maryland., de Claro RA; Division of Hematologic Malignancies I, Office of Oncologic Diseases, U.S. Food and Drug Administration, Silver Spring, Maryland., Waldron PE; Division of Pharmacovigilance, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration, Silver Spring, Maryland.

Publikováno v: American journal of hematology [Am J Hematol] 2020 Dec; Vol. 95 (12), pp. E332-E335. Date of Electronic Publication: 2020 Sep 30.

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Review

Proteasome inhibitor-associated thrombotic microangiopathy: A review of cases reported to the FDA adverse event reporting system and published in the literature.

Autor: Nguyen MN; Division of Pharmacovigilance, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Nayernama A; Division of Pharmacovigilance, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Jones SC; Division of Pharmacovigilance, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Kanapuru B; Division of Hematologic Malignancies, Office of Oncologic Diseases, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Gormley N; Division of Hematologic Malignancies, Office of Oncologic Diseases, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Waldron PE; Division of Pharmacovigilance, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Publikováno v: American journal of hematology [Am J Hematol] 2020 Sep; Vol. 95 (9), pp. E218-E222. Date of Electronic Publication: 2020 Apr 29.

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Editorial & Opinion

Antibiotic prophylaxis in vaccinated eculizumab recipients who developed meningococcal disease.

Autor: Crew PE; Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. Electronic address: Page.Crew@fda.hhs.gov., McNamara L; Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA., Waldron PE; Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., McCulley L; Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Christopher Jones S; Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Bersoff-Matcha SJ; Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA; Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Publikováno v: The Journal of infection [J Infect] 2020 Mar; Vol. 80 (3), pp. 350-371. Date of Electronic Publication: 2019 Nov 26.

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