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FDA publishes for review and comment the International Council for Harmonization M4Q(R2) guidance establishing the location and st...[ Price : $8.95]
FDA warns Integrity Partners St. Louis, MO-based Chemisphere drug manufacturing facility about CGMP issues in its production of fi...[ Price : $8.95]
Valneva says it has voluntarily withdrawn its BLA for Ixchiq, the companys chikungunya vaccine, based on FDA safety-related restri...[ Price : $8.95]
FDA accepts for priority review a Celcuity NDA for gedatolisib in patients with hormone receptorpositive, HER2-negative, PIK3CA wi...[ 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 ...[ 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...