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FDA accepts for review an Ariad Pharmaceuticals NDA for brigatinib, an investigational oral anaplastic lymphoma kinase inhibitor f...[ Price : $8.95]
Washington Legal Foundation and the National Association of Manufacturers ask the 3rd Circuit Appeals Court to reject a Pennsylvan...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Beijing Taiyang Pharmaceutical Industry, Option Care Enterprises, and Wellcare R...[ Price : $8.95]
FDA accepts for priority review a Novartis NDA for LEE011 (ribociclib) as a first-line treatment of postmenopausal women with horm...[ Price : $8.95]
FDA warns Chinas Beijing Taiyang Pharmaceutical Co. about limiting and refusing an agency inspection and CGMP deviations.[ Price : $8.95]
Federal Register Proposed Rule comment extension: FDA extends the comment period for an 8/24 proposed rule to amend the regulation...[ Price : $8.95]
Federal Register Notice. FDA makes available a guidance on Labeling for Permanent Hysteroscopically Placed Tubal Implants Intended...[ Price : $8.95]
The latest FDA report on the status of postmarketing requirements and commitments shows that drug and biologic companies submit an...