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Aisa Pharma wins an FDA orphan drug designation for its investigational drug AISA-021 (cilnidipine) and its use in treating system...[ Price : $8.95]
FDA warns Zydus Lifesciences Limited about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA warns Denver, CO-based Optikem International about Quality System Regulation and other violations in its production of ophthal...[ Price : $8.95]
Three trade groups representing companies regulated by FDA recommend changes to a draft guidance on addressing misinformation abou...[ Price : $8.95]
FDA clears Sonic Incytes Velacur Determined Fat Fraction measuring tool.[ Price : $8.95]
Federal Register notice: FDA announces that it approved Incytes Opzelura (ruxolitinib) using a rare pediatric disease priority rev...[ Price : $8.95]
CDER director Patrizia Cavazzoni tells a drug regulatory conference that FDA is considering more opportunities for sponsors to lea...[ Price : $8.95]
Federal Register notice: FDA classifies endoscopic pancreatic debridement devices into Class 2 (special controls).