[ 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]
Moderna and Merck report updated five-year follow-up data that show their personalized mRNA cancer vaccine candidate, intismeran a...[ Price : $8.95]
FDA asks Capricor Therapeutics for a full clinical study report from the companys Phase 3 HOPE-3 trial as part of its ongoing BLA ...[ 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Valneva says it has voluntarily withdrawn its BLA for Ixchiq, the companys chikungunya vaccine, based on FDA safety-related restri...[ Price : $8.95]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 inspectors cite Oklahoma-based outsourcing facility Qualgen for a wide range of manufacturing and quality control failures dur...