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Accelerated approval

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Lung Cancer
AbbVie’s ADC Nabs Accelerated Approval for Lung Cancer
AbbVie’s Emrelis is the first non-small cell lung cancer therapy approved for patients with high c-Met expression levels who have received prior lines of treatment.
May 15, 2025
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2 min read
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Tristan Manalac
Entrance to the U.S. Department of Health and Human Services in Washington, DC
Accelerated approval
Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, Sarepta’s Exondys and Covis’ Makena.
January 15, 2025
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2 min read
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Tristan Manalac
Document checking, agreement or contract validation, financial or budget analysis, search for document files concept, businessman manager holding big magnifying glass checking document paper.
FDA
When Are Confirmatory Trials ‘Underway’? FDA Releases New Accelerated Approval Guidance
Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for confirmatory trials for therapies seeking the shortened path to market.
January 7, 2025
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3 min read
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Heather McKenzie
Regulatory
Deep Dive: FDA’s Accelerated Approval Pathway Under Fire
In this deep dive BioSpace explores the opportunities and challenges presented by the FDA’s accelerated approval program.
November 18, 2024
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2 min read
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Heather McKenzie
PRESS RELEASES
Press Releases
OS Therapies Requests Meeting with FDA to Gain Agreement on Surrogate Endpoint(s) for Breakthrough Therapy Designation & Accelerated Approval of OST-HER2 in the Prevention of Recurrence of Fully Resected, Lung Metastatic Osteosarcoma
April 7, 2025
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7 min read
Press Releases
Mesoblast Files Request for Type B Meeting with FDA to Discuss Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure
April 3, 2025
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5 min read
Press Releases
Novartis receives FDA accelerated approval for Vanrafia® (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy (IgAN)
April 3, 2025
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21 min read