Duchenne muscular dystrophy is a severe, progressive, X-linked neuromuscular disease affecting approximately one in 5,000 male births. It is caused by mutations in the DMD gene that prevent the ...
Andelyn Biosciences, a leading contract development and manufacturing organization, announced today that Genprex, Inc. has selected Andelyn to support scale-up manufacturing for its diabetes gene ...
Expanding clinical pipelines and outsourcing are boosting CDMO demand. Opportunities include scalable cell/vector production, non-viral platforms, automation and faster analytics.Dublin, Aug. 26, 2026 ...
The single global Phase 3 trial, ArMaDa3 (NCT07770828), is the first pivotal gene therapy trial in geographic atrophy (GA)U.S. Food and Drug ...
On June 24, 2026, the U.S. Food and Drug Administration (FDA) released a draft update to its 2019 draft guidance titled “Demonstrating ...
How do you approach clinical trial design for cell and gene therapies? There are a lot of similarities, but also some notable differences that I have encountered the last 15 years working in multiple ...
Manufacturing activities are expected to include process optimization, scale-up, analytical qualification, and potency assay ...
Andelyn Biosciences, Inc., a leading patient-focused cell and gene therapy Contract Development and Manufacturing ...
In this GEN webinar, experts from Rose BioSolutions, a CDMO and Cell Solutions organization formed from Charles River Laboratories’ businesses, will discuss how integrating regulatory strategy at the ...
The FDA has put a clinical hold on Regenxbio’s RGX-121 over asymptomatic spine MRI findings, derailing the biotech’s plans to ...
The FDA has granted accelerated approval of a gene therapy to treat children and adults aged at least 8 years with glycogen ...
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