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428,602 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
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
Quantum-Si to Develop Acceleration Platform and Advance Core Technologies in Collaboration with NVIDIA
November 20, 2024
·
5 min read
Press Releases
ADVA Biotechnology and Cellipont Bioservices Showcase Accelerated Transition from R&D to GMP at Advanced Therapies Week 2025
January 13, 2025
·
2 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
Press Releases
Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma
January 21, 2025
·
5 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
Press Releases
Chimerix Submits Dordaviprone New Drug Application for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma
December 30, 2024
·
4 min read
Press Releases
Alzheimer’s Drug Discovery Foundation’s Diagnostics Accelerator (DxA) invests $10M in Alamar Biosciences, Inc. to Advance Precision Medicine in Alzheimer’s Disease
January 8, 2025
·
5 min read
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
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