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The U.S. Food and Drug Administration has approved Waskyra (etuvetidigene autotemcel), the first cell-based gene therapy for ...
Paris Margaritis, DPhil, is a professional with over 28 years of experience in AAV gene therapy for hemophilia. A key focus of his work has been treating hemophilia patients with inhibitors. He earned ...
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. The Food and Drug Administration has rejected what was ...
In a highly anticipated article, FDA officials Vinay Prasad, M.D., and Martin Makary, M.D., outlined a novel regulatory pathway that could trigger a seismic shift in how bespoke gene editing therapies ...
The sudden departure of Vinay Prasad, M.D., from the FDA this week again threw the cell and gene therapy field into uncertainty. But this time, the unknown is hitting the industry in a different way ...
Ori Biotech has lassoed a significant milestone for its space- and cost-efficient cell and gene therapy manufacturing platform. The FDA has granted the company’s IRO platform an Advanced Manufacturing ...
FDA approves 1st gene therapy for Wiskott-Aldrich syndrome, offering a new treatment for patients lacking matched stem cell donors.
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