Cancer Drugs Dominate Approval Landscape

In a dramatic upsurge since the 1980s, cancer drugs now account for more than one-fourth of all new drug approvals in the United States since 2010, up from 4% a few decades ago, according to a new analysis from the Tufts Center for the Study of Drug Development (CSDD). From 1980 through 2018, the U.S. […]

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FDA Issues Guidance on Placebo-Controlled Design in Hematologic, Oncology Trials

With the clear understanding that using a placebo in randomized controlled clinical trials of therapies to treat hematologic malignancy and oncologic disease for which there is known effective therapy is ethically unacceptable, sponsors should consider using a placebo-controlled design only in specific, narrow circumstances, the U.S. Food and Drug Administration (FDA) says in a