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FDA says that Merck and Pfizers avelumab is a breakthrough therapy for patients with metastatic Merkel cell carcinoma.[ Price : $8.95]
FDA makes presentations biomarkers, the benefit/risk framework, and patient-reported outcomes at a PDUFA 6 reauthorization stakeho...[ Price : $8.95]
CDRH director Jeffrey Shuren says his Center intends to finalize early next year its guidance on aFramework for Regulatory Oversig...[ Price : $8.95]
FDA issues AngioDynamics a close-out letter effectively resolving promotional issues raised in a 2011 Warning Letter involving its...[ Price : $8.95]
Federal Register Notice: FDA publishes a list of approved PMAs and their safety and effectiveness summaries.[ Price : $8.95]
The Washington Legal Foundation calls on the Centers for Disease Control and Prevention (CDC) to withdraw its Draft Guideline for ...[ Price : $8.95]
FDA says Hikma Pharmaceuticals has sufficiently corrected GMP violations at its Portuguese drug manufacturing facility.[ Price : $8.95]
FDA accepts Sandoz regulatory submission for a biosimilar of Amgens Neulasta.