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426,916 Results for "advanced accelerator applications".
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Press Releases
Sonrai Accelerates Cancer Therapeutics Research with Advanced Analytics
November 6, 2024
·
2 min read
Press Releases
Quantum-Si to Develop Acceleration Platform and Advance Core Technologies in Collaboration with NVIDIA
November 20, 2024
·
5 min read
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
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
Press Releases
Assembly Biosciences Announces $30.1 Million Equity Investment and Accelerated Funding from Gilead to Advance Clinical Development Programs
December 19, 2024
·
6 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
Press Releases
Solid Biosciences Announces Collaboration with Mayo Clinic to Accelerate Gene Therapy Innovation and Advance Development of Cardiac Gene Therapies
December 4, 2024
·
6 min read
Press Releases
Replimune Receives Breakthrough Therapy Designation for RP1 and Submits RP1 Biologics License Application to the FDA under the Accelerated Approval Pathway
November 22, 2024
·
4 min read
Regulatory
FDA Outlines Accelerated Review Guidelines in Waning Days of Biden Administration
The program has recently become controversial as a number of high-profile advanced approvals were granted only for the drugs to fail a confirmatory trial later on. Now, the FDA has clearly laid out expectations.
December 6, 2024
·
3 min read
·
Annalee Armstrong
Job Trends
Thermo Fisher Scientific Opens New GMP-certified Ultra-cold Facility in the EU to Accelerate Advanced Therapies Development
Thermo Fisher Scientific Inc., the world leader in serving science, has opened a new clinical and commercial ultra-cold facility in the EU, expanding its clinical trial network in Europe to help accelerate the development of advanced therapies.
June 3, 2024
·
3 min read
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