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FDA grants Merck a breakthrough therapy designation for Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients with ...[ Price : $8.95]
Vertex Pharmaceuticals says it received a subpoena from the U.S. Department of Justice in the third quarter related to its Good La...[ Price : $8.95]
HHS Office of Inspector General plans to examine how FDA requires NDA holders to conduct postmarketing studies and the agencys ove...[ Price : $8.95]
FDA grants PathMaker Neurosystems an Expedited Access Pathway designation for its MyoRegulator PM-2200 system for use in treating ...[ Price : $8.95]
Federal Register Notice: FDA issues a revised guidance: DSCSA Implementation: Product Tracing Requirements for Dispensers Complia...[ Price : $8.95]
Federal Register Notice: FDA releases a document for industry: Draft Guidance on Progesterone to provide recommendations on bioequ...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Information to Support a Claim of Electromagnetic Compatibility (EMC) of E...[ Price : $8.95]
Federal Register Final order: FDA classifies a gastrointestinal assay into Class 2.