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Tissue-Agnostic Drug Development: A New Path to Drug Approval

Cancer discovery, 2021-09, Vol.11 (9), p.2139-2144

2021

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Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development

Cancer discovery, 2023-12, Vol.13 (12), p.2515-2524

2023

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Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy

Current oncology reports, 2020-11, Vol.22 (11), p.116-116, Article 116

2020

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Biosimilars: Here and Now

American Society of Clinical Oncology educational book, 2016, Vol.36 (36), p.e151-e157

2016

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U.S. Food and Drug Administration Approval: Rituximab in Combination with Fludarabine and Cyclophosphamide for the Treatment of Patients with Chronic Lymphocytic Leukemia

The oncologist (Dayton, Ohio), 2011-01, Vol.16 (1), p.97-104

2011

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A pilot study evaluating the safety and CD34+ cell mobilizing activity of escalating doses of plerixafor in healthy volunteers

British journal of haematology, 2011-04, Vol.153 (1), p.66-75

2011

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Biosimilars: Here and Now

American Society of Clinical Oncology educational book, 2016-05, Vol.35 (36), p.e151-e157

2016

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When One Is a Hammer, Everything Looks Like a Nail

Journal of oncology practice, 2017-09, Vol.13 (9_suppl), p.10s-11s

Lemery, Steven J

2017

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FDA analysis of the characteristics and relevance of serious adverse events that are Grade 1 or 2 in severity

Journal of clinical oncology, 2016-05, Vol.34 (15_suppl), p.2538-2538

2016

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Food and Drug Administration analysis of 1332 single patient and emergency use expanded access (compassionate use) requests for patients with cancer over a duration of three years (2012-2014)

Journal of clinical oncology, 2016-05, Vol.34 (15_suppl), p.6523-6523

2016

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Daclizumab-Associated Erythroderma Is Associated with Rebound Increases in CD25-Positive CD4 Cells Following Treatment of Aplastic Anemia and Pure Red Cell Aplasia

Blood, 2005-11, Vol.106 (11), p.1042-1042

2005

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A Pilot Study Evaluating the CD34+ Cell Mobilizing Activity and Adverse Events Associated with Escalating Doses of AMD3100 in Healthy Volunteers

Blood, 2007-11, Vol.110 (11), p.3278-3278

2007

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Lineage Analysis of the FIPL1-PDGFRα Fusion Gene in Myeloproliferative Hypereosinophilic Syndrome

Blood, 2004-11, Vol.104 (11), p.2441-2441

2004

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62 - Immunohematologic disorders

Clinical Immunology, p.921-934

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Geographical and baseline clinical characteristics of participants enrolled in hepatocellular carcinoma (HCC) trials: Analysis of US FDA approvals

Journal of clinical oncology, 2023-06, Vol.41 (16_suppl), p.4115-4115

2023

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FDA analysis of treatment efficacy based on etiology of hepatocellular carcinoma

Journal of clinical oncology, 2023-06, Vol.41 (16_suppl), p.4117-4117

2023

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FDA analysis of grade 3-4 safety events

Journal of clinical oncology, 2017-05, Vol.35 (15_suppl), p.2544-2544

2017

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U.S. FDA analysis of enrollment of Asian patients from India in cancer clinical trials leading to approval from 2010 to 2022

Journal of clinical oncology, 2024-06, Vol.42 (16_suppl), p.e13779-e13779

2024

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Treatment-related toxicity and improved outcome from immunotherapy in hepatocellular cancer: Evidence from an FDA pooled analysis of landmark clinical trials with validation from routine practice

European journal of cancer (1990), 2021-11, Vol.157, p.140-152

2021

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Associations Between Wildfire‐Related PM2.5 and Intensive Care Unit Admissions in the United States, 2006–2015

Geohealth, 2021-05, Vol.5 (5), p.e2021GH000385-n/a

2021

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Association between antibiotics and adverse oncological outcomes in patients receiving targeted or immune-based therapy for hepatocellular carcinoma

JHEP reports, 2023-06, Vol.5 (6), p.100747-100747, Article 100747

2023

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Antibiotic therapy and association with oncological outcomes from targeted and immune-based therapy in hepatocellular carcinoma (HCC)

Journal of clinical oncology, 2022-06, Vol.40 (16_suppl), p.4089-4089

2022

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Multilineage involvement of the fusion gene in patients with FIP1L1/PDGFRA‐positive hypereosinophilic syndrome

British journal of haematology, 2006-02, Vol.132 (3), p.286-292

2006

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Wildfire-related PM₂.₅ and Intensive Care Unit Admissions and Bed Utilization in the United States, 2006-2015

Environmental health perspectives. Supplements, 2021-08, Vol.2021 (1)

2021

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Associations Between Wildfire-Related PM 2.5 and Intensive Care Unit Admissions in the United States, 2006-2015

Geohealth, 2021-05, Vol.5 (5), p.e2021GH000385

2021

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Tissue-Agnostic Drug Development: A New Path to Drug Approval

Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development

Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy

Biosimilars: Here and Now

U.S. Food and Drug Administration Approval: Rituximab in Combination with Fludarabine and Cyclophosphamide for the Treatment of Patients with Chronic Lymphocytic Leukemia

A pilot study evaluating the safety and CD34+ cell mobilizing activity of escalating doses of plerixafor in healthy volunteers

Biosimilars: Here and Now

When One Is a Hammer, Everything Looks Like a Nail

FDA analysis of the characteristics and relevance of serious adverse events that are Grade 1 or 2 in severity

Food and Drug Administration analysis of 1332 single patient and emergency use expanded access (compassionate use) requests for patients with cancer over a duration of three years (2012-2014)

Daclizumab-Associated Erythroderma Is Associated with Rebound Increases in CD25-Positive CD4 Cells Following Treatment of Aplastic Anemia and Pure Red Cell Aplasia

A Pilot Study Evaluating the CD34+ Cell Mobilizing Activity and Adverse Events Associated with Escalating Doses of AMD3100 in Healthy Volunteers

Lineage Analysis of the FIPL1-PDGFRα Fusion Gene in Myeloproliferative Hypereosinophilic Syndrome

62 - Immunohematologic disorders

Geographical and baseline clinical characteristics of participants enrolled in hepatocellular carcinoma (HCC) trials: Analysis of US FDA approvals

FDA analysis of treatment efficacy based on etiology of hepatocellular carcinoma

FDA analysis of grade 3-4 safety events

U.S. FDA analysis of enrollment of Asian patients from India in cancer clinical trials leading to approval from 2010 to 2022

Treatment-related toxicity and improved outcome from immunotherapy in hepatocellular cancer: Evidence from an FDA pooled analysis of landmark clinical trials with validation from routine practice

Associations Between Wildfire‐Related PM2.5 and Intensive Care Unit Admissions in the United States, 2006–2015

Association between antibiotics and adverse oncological outcomes in patients receiving targeted or immune-based therapy for hepatocellular carcinoma

Antibiotic therapy and association with oncological outcomes from targeted and immune-based therapy in hepatocellular carcinoma (HCC)

Multilineage involvement of the fusion gene in patients with FIP1L1/PDGFRA‐positive hypereosinophilic syndrome

Wildfire-related PM₂.₅ and Intensive Care Unit Admissions and Bed Utilization in the United States, 2006-2015

Associations Between Wildfire-Related PM 2.5 and Intensive Care Unit Admissions in the United States, 2006-2015

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