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Written by:Makoto Tsunozaki, Ph.D. and Jane Dai, Ph.D. We previously reported a decision by the U.S. Food and Drug Administration (FDA)... Read More »
Written by: Phillip J. Minnick, Ph.D.   Zydus Lifesciences Limited announced on March 11, 2025, that it entered into ... Read More »
Written by: Douglas W. Crandell, Ph.D. and Eric Furman, Ph.D. Drug development programs face unique challenges in demonstrating the... Read More »
Written by: Alistair J. McIntyre and Agnes Juang, Ph.D. On March 17, 2025, a bipartisan group of senators introduced two bills... Read More »
Written by: Susan M. Janicki, Ph.D. and Joseph Mallon, Ph.D. On March 6, 2025, the National Institutes of Health (NIH) announced plans ... Read More »
Written by:Kenneth O. Aruda, Ph.D. and Nathan D. Reeves RESTEM, LLC v. JADI CELL, LLC Before Moore, Schall, and Taranto. Appeal... Read More »
Written by:James Raleigh and Daniel Kiang IMMUNOGEN, INC. v. STEWART Before Lourie, Dyk, and Prost.  Appeal from the United... Read More »
Written by: Rhett D. Ramsey and Robert J. Hilton, Ph.D. Congress authorized the FDA to determine whether a drug is “in shortage... Read More »
Written by: Bailey R. Arenberg and Jason J. Jardine Effective January 28, 2025, the new administration suspended the Climate Change... Read More »
Written by:Bailey R. Arenberg & Jason J. Jardine With the recent convocation of the 119th Congress, a change in administration, and... Read More »
Written by:Geetha Durairaj, Ph.D. & Jason J. Jardine On January 16th, 2025, GT Medical Technologies, announced that it has raised $37... Read More »
Written by:Ari Feinstein and Joseph Mallon, Ph.D. On October 11, 2024, Edwards[1] filed a petition for a writ of certiorari with the U.S... Read More »
Written by: Jason J. Jardine, Justin Culbertson, Ph.D. & Phillip J. Minnick, Ph.D. The sun is officially setting on the United... Read More »
Written by: Makoto Tsunozaki, Ph.D. & Agnes Juang, Ph.D. On October 22, 2024, Novo Nordisk made a submission to the U.S. Food and... Read More »
Written by: Alistair J. McIntyre and Eric Furman, Ph.D. On November 21, 2024, the FDA’s Center for Devices and Radiological... Read More »
Written by: Douglas W. Crandell, Ph.D. and Joseph Mallon, Ph.D. A recent article[1] authored by Haider J. Warraich, MD[2]; Troy... Read More »
Written by: Kenneth O. Aruda, Ph.D. & Jason J. Jardine In the ongoing case of Carefirst of Maryland Inc. v. Johnson &... Read More »
Written by: Susan M. Janicki, Ph.D. & Robert J. Hilton, Ph.D. On October 2, 2024, the U.S. Department of Agriculture (USDA), U.S... Read More »
Written by: Ashley C. Morales & Jane Dai, Ph.D. On October 7, 2024, the 2024 Nobel Prize in Physiology or Medicine was jointly... Read More »
Written by: Makoto Tsunozaki, Ph.D. & Jason J. Jardine On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a... Read More »
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