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89,139 Results for "triphase accelerator".
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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
·
2 min read
·
Tristan Manalac
Press Releases
Celerius and Inquisite Partner to Accelerate Clinical Research with AI
April 22, 2025
·
1 min read
Press Releases
Precision Neuroscience Adds Med-Tech Veterans To Accelerate Commercialization
May 1, 2025
·
3 min read
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
·
2 min read
·
Heather McKenzie
Neurodegenerative disease
UniQure Clears Path to Accelerated Approval for Huntington’s Gene Therapy
In a Type B meeting, the FDA signified that it will allow uniQure to use a natural history control, the composite Unified Huntington’s Disease Rating Scale, and neurofilament light chain levels to support the accelerated approval of its gene therapy AMT-130.
December 10, 2024
·
2 min read
·
Tristan Manalac
Press Releases
TNF Pharmaceuticals and Renova Health Utilize AI to Accelerate Drug Development
April 22, 2025
·
6 min read
Press Releases
Thermo Fisher Scientific Leverages Integrated Solutions to Accelerate the Development of Biologic Therapeutics
April 29, 2025
·
2 min read
Editorial
FDA’s Accelerated Approval Pathway Drives Momentum for Intractable, Fatal Diseases
Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track record of propelling R&D for some of medicine’s most challenging illnesses.
December 2, 2024
·
6 min read
·
Heather McKenzie
FDA
5 Accelerated Approvals Gone Wrong
Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials.
October 14, 2024
·
7 min read
·
Heather McKenzie
Press Releases
OKYO Pharma Announces Plans to Accelerate the Clinical Development of Urcosimod to Treat Neuropathic Corneal Pain
May 1, 2025
·
4 min read
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