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Articles (61)

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1-10 of 61 results for Breakthrough therapy Designation

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Select article: The Impact of Breakthrough Therapy Designation on Drug Safety

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Research article

First published 2025

The Impact of Breakthrough Therapy Designation on Drug Safety

Hanu Tyagi, Rachna Shah

Production and Operations Management

Select article: Breakthrough Therapy Designation

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Other

First published 2015-3

Breakthrough Therapy Designation

Arpita Shah

Therapeutic Innovation & Regulatory Science

Select article: Breakthrough Therapy Designation

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Research article

First published 2017-7

Breakthrough Therapy Designation

Ryan Conrad, Kimberly Taylor, Miranda Raggio [...]

Therapeutic Innovation & Regulatory Science

Select article: The Current Status of Sakigake Designation in Japan,PRIME in the European Union,and Breakthrough Therapy Designation in the United States

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Research article

First published 2017-1

The Current Status of Sakigake Designation in Japan,PRIME in the European Union,and Breakthrough Therapy Designation in the United States

Hideyuki Kondo, Toshiyuki Hata, Konomi Ito [...]

Therapeutic Innovation & Regulatory Science

Select article: Obinutuzumab for chronic lymphocytic leukemia: promise of the first treatment approved with breakthrough therapy designation

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Review article

First published 2015-10

Obinutuzumab for chronic lymphocytic leukemia: promise of the first treatment approved with breakthrough therapy designation

Ashish Kumar Kakkar, Sadasivam Balakrishnan

Journal of Oncology Pharmacy Practice

Select article: Pulmonary Arterial Hypertension: A Case Study in FDA Expedited Program Designations

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Research article

First published 2019-3

Pulmonary Arterial Hypertension: A Case Study in FDA Expedited Program Designations

Iraj Daizadeh

Therapeutic Innovation & Regulatory Science

Select article: Breakthrough Therapy,PRIME and Sakigake: A Comparison Between Neuroscience and Oncology in Obtaining Preferred Regulatory Status

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Research article

First published 2019

Breakthrough Therapy,PRIME and Sakigake: A Comparison Between Neuroscience and Oncology in Obtaining Preferred Regulatory Status

Elena Tomaselli Muensterman, Yijia Luo, Jonathon M. Parker

Therapeutic Innovation & Regulatory Science

Select article: Accelerated Pathways Work—Now What? A Survey of Payers in the United States

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Research article

First published 2017-3

Accelerated Pathways Work—Now What? A Survey of Payers in the United States

Barry Farrimond, Jonathan J. Fleming, Mark Mathieu

Therapeutic Innovation & Regulatory Science

Select article: FDA’s Expedited Programs and Their Impact on the Availability of New Therapies

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Research article

First published 2017-1

FDA’s Expedited Programs and Their Impact on the Availability of New Therapies

Nehar Damle, Shilvi Shah, Praneeta Nagraj [...]

Therapeutic Innovation & Regulatory Science

Select article: Influence of Expedited Programs in the United States on Oncology Drug Development in Japan

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Research article

First published 2019-3

Influence of Expedited Programs in the United States on Oncology Drug Development in Japan

Makoto Tanaka, Naoki Matsumaru, Katsura Tsukamoto

Therapeutic Innovation & Regulatory Science

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