On Biostatistics and Clinical Trials
CQ's web blog on the issues in biostatistics and clinical trials.
Showing posts with label
Accelerated approval
.
Show all posts
Showing posts with label
Accelerated approval
.
Show all posts
Sunday, June 23, 2024
Elevidys in DMD: Approved Despite Trial Failed in Primary Efficacy Endpoint
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The US Food and Drug Administration has given the green light for the first gene therapy that treats a rare form of muscular dystrophy ( Du...
Saturday, April 01, 2023
"Ensuring Public Trust in an Empowered FDA" - Accelerated Approval
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In the latest issue of New England Journal of Medicine , Drs Ross, Berg, and Ramachandran wrote a paper: " Ensuring Public Trust in an...
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