[ Price : $8.95]
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Valneva says it has voluntarily withdrawn its BLA for Ixchiq, the companys chikungunya vaccine, based on FDA safety-related restri...[ Price : $8.95]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 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FDA posts a draft guidance outlining how drug developers can use minimal residual disease and complete response as primary endpoin...[ Price : $8.95]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 inspectors cite Oklahoma-based outsourcing facility Qualgen for a wide range of manufacturing and quality control failures dur...