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An FDA oncology analysis of antibody-drug conjugates

Regulatory toxicology and pharmacology, 2015-04, Vol.71 (3), p.444-452

2015

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U.S. Food and Drug Administration Approval Summary: Brentuximab Vedotin for the Treatment of Relapsed Hodgkin Lymphoma or Relapsed Systemic Anaplastic Large-Cell Lymphoma

Clinical cancer research, 2012-11, Vol.18 (21), p.5845-5849

2012

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Sorafenib for the Treatment of Advanced Renal Cell Carcinoma

Clinical cancer research, 2006-12, Vol.12 (24), p.7271-7278

2006

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An FDA oncology analysis of immune activating products and first-in-human dose selection

Regulatory toxicology and pharmacology, 2016-11, Vol.81, p.448-456

2016

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Sprycel for Chronic Myeloid Leukemia and Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib Mesylate

Clinical cancer research, 2008-01, Vol.14 (2), p.352-359

2008

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U.S. Food and Drug Administration Approval Summary: Omacetaxine Mepesuccinate as Treatment for Chronic Myeloid Leukemia

The oncologist (Dayton, Ohio), 2014-01, Vol.19 (1), p.94-99

2014

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Clinical Development of Cancer Drugs in Combination With External Beam Radiation Therapy: US Food and Drug Administration Perspective

International journal of radiation oncology, biology, physics, 2017-05, Vol.98 (1), p.5-7

2017

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An FDA oncology analysis of toxicities associated with PBD-containing antibody-drug conjugates

Regulatory toxicology and pharmacology, 2019-10, Vol.107, p.104429, Article 104429

2019

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Trends in the approval of cancer therapies by the FDA in the twenty-first century

Nature reviews. Drug discovery, 2023-08, Vol.22 (8), p.625-640

2023

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Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology

Regulatory toxicology and pharmacology, 2024-05, Vol.149, p.105616-105616, Article 105616

2024

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FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

Clinical cancer research, 2015-06, Vol.21 (12), p.2666-2670

2015

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An FDA oncology analysis of CD3 bispecific constructs and first-in-human dose selection

Regulatory toxicology and pharmacology, 2017-11, Vol.90, p.144-152

2017

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FDA approval: idelalisib monotherapy for the treatment of patients with follicular lymphoma and small lymphocytic lymphoma

Clinical cancer research, 2015-04, Vol.21 (7), p.1525-1529

2015

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FDA approval: siltuximab for the treatment of patients with multicentric Castleman disease

Clinical cancer research, 2015-03, Vol.21 (5), p.950-954

2015

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FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia

Clinical cancer research, 2015-08, Vol.21 (16), p.3586-3590

2015

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Measuring ovarian toxicity in clinical trials: an American Society of Clinical Oncology research statement

The lancet oncology, 2023-10, Vol.24 (10), p.e415-e423

2023

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U.S. Food and Drug Administration Approval: Ruxolitinib for the Treatment of Patients with Intermediate and High-Risk Myelofibrosis

Clinical cancer research, 2012-06, Vol.18 (12), p.3212-3217

2012

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An FDA oncology view of juvenile animal studies in support of initial pediatric trials for anticancer drugs

Regulatory toxicology and pharmacology, 2016-08, Vol.79, p.142-143

2016

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An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products

Regulatory toxicology and pharmacology, 2020-02, Vol.110, p.104511, Article 104511

2020

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FDA Review Summary: Mozobil in Combination with Granulocyte Colony-Stimulating Factor to Mobilize Hematopoietic Stem Cells to the Peripheral Blood for Collection and Subsequent Autologous Transplantation

Oncology, 2010-01, Vol.78 (3-4), p.282-288

2010

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U.S. Food and Drug Administration Approval: Obinutuzumab in Combination with Chlorambucil for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia

Clinical cancer research, 2014-08, Vol.20 (15), p.3902-3907

2014

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Challenges of routine diabetes care during COVID-19 era: A systematic search and narrative review

Primary care diabetes, 2021-12, Vol.15 (6), p.918-922

2021

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Role of Nongovernmental Organizations in Controlling COVID-19

Disaster medicine and public health preparedness, 2022-10, Vol.16 (5), p.1705-1705

2022

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Role of nation’s culture on COVID-19 prevention

International journal of social psychiatry, 2021-11, Vol.67 (7), p.961-962

2021

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Development of quality indicators to measure pre-hospital emergency medical services for road traffic injury

BMC health services research, 2021-03, Vol.21 (1), p.235-235, Article 235

2021

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An FDA oncology analysis of antibody-drug conjugates

U.S. Food and Drug Administration Approval Summary: Brentuximab Vedotin for the Treatment of Relapsed Hodgkin Lymphoma or Relapsed Systemic Anaplastic Large-Cell Lymphoma

Sorafenib for the Treatment of Advanced Renal Cell Carcinoma

An FDA oncology analysis of immune activating products and first-in-human dose selection

Sprycel for Chronic Myeloid Leukemia and Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib Mesylate

U.S. Food and Drug Administration Approval Summary: Omacetaxine Mepesuccinate as Treatment for Chronic Myeloid Leukemia

Clinical Development of Cancer Drugs in Combination With External Beam Radiation Therapy: US Food and Drug Administration Perspective

An FDA oncology analysis of toxicities associated with PBD-containing antibody-drug conjugates

Trends in the approval of cancer therapies by the FDA in the twenty-first century

Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology

FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

An FDA oncology analysis of CD3 bispecific constructs and first-in-human dose selection

FDA approval: idelalisib monotherapy for the treatment of patients with follicular lymphoma and small lymphocytic lymphoma

FDA approval: siltuximab for the treatment of patients with multicentric Castleman disease

FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia

Measuring ovarian toxicity in clinical trials: an American Society of Clinical Oncology research statement

U.S. Food and Drug Administration Approval: Ruxolitinib for the Treatment of Patients with Intermediate and High-Risk Myelofibrosis

An FDA oncology view of juvenile animal studies in support of initial pediatric trials for anticancer drugs

An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products

FDA Review Summary: Mozobil in Combination with Granulocyte Colony-Stimulating Factor to Mobilize Hematopoietic Stem Cells to the Peripheral Blood for Collection and Subsequent Autologous Transplantation

U.S. Food and Drug Administration Approval: Obinutuzumab in Combination with Chlorambucil for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia

Challenges of routine diabetes care during COVID-19 era: A systematic search and narrative review

Role of Nongovernmental Organizations in Controlling COVID-19

Role of nation’s culture on COVID-19 prevention

Development of quality indicators to measure pre-hospital emergency medical services for road traffic injury

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