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86,586 Results for "triphase accelerator".
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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
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
FDA
Evolving FDA Accelerated Approval Pathway Suffers Spate of Withdrawals
As therapies for rare and neurological diseases earn accelerated approval, experts laud the program’s intent while remaining concerned about confirmatory trials and clinical efficacy, especially as products greenlit under this pathway are pulled from the market.
October 28, 2024
·
7 min read
·
Heather McKenzie
Genetown
Neutron Therapeutics’ Accelerator Receives Final Acceptance at University of Birmingham’s High Flux Accelerator-Driven Neutron Facility
Neutron Therapeutics, a leading developer of accelerator-based neutron systems for targeted radiation therapy of solid tumors, today announced that its compact accelerator has received final acceptance for use at the University of Birmingham’s High Flux Accelerator-Driven Neutron Facility.
December 13, 2023
·
3 min read
Regulatory
Sangamo’s Fabry Gene Therapy Could Hit Market 3 Years Earlier With FDA Accelerated Approval Pathway
The regulator agreed to allow Sangamo Therapeutics to use data to seek accelerated approval for its Fabry gene therapy candidate, eliminating the need for an additional registrational study and potentially shortening the time-to-market by three years.
October 23, 2024
·
2 min read
·
Tristan Manalac
Press Releases
Verismo Therapeutics Completes Merger to Accelerate Clinical Development
December 20, 2024
·
4 min read
Opinion
What Accelerated Approval’s Naysayers Miss
By speeding lifesaving drugs’ way to market and focusing on the underlying causes of disease, the pathway has helped save many lives.
December 9, 2024
·
5 min read
·
Emil Kakkis
FDA
Accelerate Diagnostics Announces FDA Clearance of its Accelerate Arc™ System
September 30, 2024
·
6 min read
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