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FDA accepts for review an Apotex submission for a biosimilar version of Amgens Neulasta (pegfilgrastim), indicated for boosting wh...[ Price : $8.95]
The 4th Circuit Appeals Court rejects the FDA bundle of rights theory that held that original and reissued patents are just one pa...[ Price : $8.95]
Sens. Warren, Feinstein, and Gillibrand ask the secretaries of HHS, Agriculture, and Defense questions about FDAs authority to mon...[ Price : $8.95]
FDA commissioner Margaret Hamburg says the agency is moving forward on several fronts to prevent a repeat of contaminated compound...[ Price : $8.95]
FDA issues Pozen a second complete response letter (CRL)on its NDA for Yosprala (aspirin and omeprazole) delayed release tablets, ...[ Price : $8.95]
FDA clears Sorin Groups Memo 3D ReChord annuloplasty ring for mitral valve repair.[ Price : $8.95]
FDA grants priority review for Cohera Medicals Sylys Surgical Sealant to help reduce anastomotic leakage in gastrointestinal proce...[ Price : $8.95]
FDA approves a Cerus Corp. BLA for its Intercept Blood System for plasma, a pathogen reduction system for reducing the risk of tra...