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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
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
Press Releases
Osivax Secures Strategic Funding to Accelerate the Development of its Influenza Vaccine Candidates
March 4, 2025
·
2 min read
Press Releases
FELDAN THERAPEUTICS ACCELERATES GROWTH WITH STRATEGIC INVESTMENT FROM LINEARIS VENTURES
February 18, 2025
·
2 min read
Press Releases
Clarametyx Biosciences Announces Investment by Kineticos AMR Accelerator Fund
January 29, 2025
·
2 min read
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