FDA releases draft guidance to accelerate gene therapy development

FDA Draft Guidance Allows Gene Therapy Companies to Leverage Existing Data for Faster Product Approvals

The FDA released a new draft guidance on June 2 titled "Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorpo

FDA to launch pilot program to speed up early-stage clinical trials

China creates new regulatory pathway to accelerate access to advanced biomedical therapies

China has established a new regulatory "tech track" for advanced therapies like personalized cancer treatments, cell and gene therapies, and

How excessive FDA manufacturing requirements are bottlenecking cell and gene therapy companies

The article argues that excessive FDA manufacturing requirements are crippling cell and gene therapy companies, using Grace Therapeutics as

Manufacturing and regulatory hurdles threaten cell and gene therapy progress

The article discusses how manufacturing and regulatory challenges are hindering the progress of cell and gene therapies, particularly in can

Daily briefing: Editing the epigenome with CRISPR to treat disease