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Nov 13, 2024

New Tool From EPA, FDA, and USDA Guides Developers of Genetically Modified Microorganisms Through Regulatory Landscape

Written by: Susan M. Janicki, Ph.D. & Robert J. Hilton, Ph.D. On October 2, 2024, the U.S. Department of Agriculture (USDA),... Read More

Knobbe Martens

Oct 21, 2024

Novacure’s Wearable Lung Cancer Treatment Device, Optune Lua, Receives FDA Approval

Written by: Raina Patel The FDA has granted approval for Novocure‘s wearable medical device, Optune Lua, designed to treat advanced non-small cell lung... Read More

Knobbe Martens

Sep 16, 2024

FDA Approves Colony Stimulating Factor-1 Receptor (Csf-1R) Blocking Antibody for Treatment of Chronic Graft-Versus-Host Disease (Cgvhd)

Written by: Makoto Tsunozaki, Ph.D. & Jason J. Jardine On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved... Read More

Knobbe Martens

Sep 16, 2024

FDA Approves Colony Stimulating Factor-1 Receptor (Csf-1R) Blocking Antibody for Treatment of Chronic Graft-Versus-Host Disease (Cgvhd)

Written by: Makoto Tsunozaki, Ph.D. & Jason J. Jardine On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved... Read More

Knobbe Martens

Sep 6, 2024

Science Group Sues FDA Over New Laboratory-Developed Test Rule

Written by: Alistair J. McIntyre & Agnes Juang, Ph.D. On August 19, 2024, the Association for Molecular Pathology (AMP) sued the... Read More

Knobbe Martens

Jul 26, 2024

Dr. Jeff Shuren, FDA CDRH Director, to Retire

Written by: Zachary B. Messick On July 23, 2024, Dr. Jeff Shuren, the director for the Center for Devices and... Read More