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FDA accepts for priority review a Celcuity NDA for gedatolisib in patients with hormone receptorpositive, HER2-negative, PIK3CA wi...[ Price : $8.95]
FDA warns Temecula, CA-based Prodrome Sciences USA about violations in its conduct of a clinical trial without submitting an IND.[ Price : $8.95]
FDA posts a draft guidance outlining how drug developers can use minimal residual disease and complete response as primary endpoin...[ Price : $8.95]
Novo Nordisk submits to FDA additional studies and analyses it says support its petition asking the agency to act against compound...[ Price : $8.95]
FDA alerts healthcare providers to a potentially high-risk issue involving dialysis tubing sets used with Prismaflex systems after...[ Price : $8.95]
FDA lifts a clinical hold against GH Researchs investigational antidepressant GH001, clearing the way for patient enrollment in th...[ Price : $8.95]
FDA inspectors cite Oklahoma-based outsourcing facility Qualgen for a wide range of manufacturing and quality control failures dur...[ Price : $8.95]
The U.S. Supreme Court agrees to hear a patent-infringement dispute between generic drugmaker Hikma Pharmaceuticals USA, Inc. and ...