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Accelerated approval

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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