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FDA and the Veterans Administration say they are partnering to open a virtual laboratory to evaluate health-related artificial int...[ Price : $8.95]
FDA accepts for review a PTC Therapeutics NDA resubmission for Translarna (ataluren) and its use in treating nonsense mutation Duc...[ Price : $8.95]
FDA grants Prolong Pharmaceuticals a fast-track designation for PP-007 (PEGylated carboxyhemoglobin, bovine) and its use for treat...[ Price : $8.95]
FDA accepts for review a Shanghai Henlius Biotech and Organon BLA for their biosimilar of Amgens Prolia/Xgeva (denosumab).[ Price : $8.95]
FDA warns Turkeys MedOffice Saglik Endustri Anonim Sirketi about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
FDA releases a form FDA-483 with eight observations from an inspection at a Novo Nordisk drug substance manufacturing facility in ...[ Price : $8.95]
FDA publishes a guidance setting an acceptable intake level for NITMA, a nitrosamine drug substance-related impurity, in products ...[ Price : $8.95]
FDA approves a Grifols BLA supplement for its plasma-protein based fibrin sealant Vistaseal for controlling surgical bleeding in p...