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A leading myeloma researcher says FDAs draft guidance endorsing minimal residual disease as a potential basis for accelerated drug...[ Price : $8.95]
Drug user fee negotiators confront lingering divisions over FDAs America First proposals and the structure of hiring commitments, ...[ Price : $8.95]
The U.S. Department of Justice (DoJ) says a Federal Circuit ruling on so-called generic drug skinny labels threatens to undermine ...[ Price : $8.95]
Rare disease drug developers and patient advocates are applauding a series of new guidance documents from FDA that bring long-awai...[ Price : $8.95]
The U.S. Senate Special Committee on Aging raises concerns about FDAs handling of foreign drug manufacturing violations and how th...[ Price : $8.95]
FDA accepts for priority review an Ionis Pharmaceuticals supplemental NDA for olezarsen for treating severe hypertriglyceridemia.[ Price : $8.95]
Eli Lilly reports favorable efficacy data on its investigational oral GLP-1 receptor agonist orforglipron, showing significantly g...[ Price : $8.95]
FDA commissioner Marty Makary defends the agencys scientific standards and personnel, particularly CBER director Vinay Prasad, ami...