The FDA’s plan to modernize its IT infrastructure features several improvements that will benefit clinical trials and sponsors, including upgrades to data-sharing and electronic submissions, support for responsible use of AI/machine learning (ML) and increased collaboration between the agency and industry.
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Developers of graft-versus-host disease (GVHD) therapies can design trials based on a new FDA draft guidance that focuses on using biomarkers to identify individual patients’ specific immune dysfunction rather than suppressing the entire immune system.
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This week’s Pipeline features a phase 1 trial approval for Alpha-1 antitrypsin deficiency, trial initiations for spinal muscular atrophy, spinal cord injury and obstructive sleep apnea, and another FDA approval for blockbuster diabetes drug Jardiance.
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