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FDA grants Takeda Pharmaceutical Co. a priority review for its NDA for ixazomib, the first investigational oral proteasome inhibit...[ Price : $8.95]
Ropes & Gray attorneys outline the FDA draft guidance on biosimilar naming and questions that are left unanswered pending public c...[ Price : $8.95]
Pacira asks a New York federal court to overturn an FDA Warning Letter preventing the company from making truthful, non-misleading...[ Price : $8.95]
FDA approves a New Haven Pharmaceuticals NDA for Durlaza (aspirin), a 24-hour, extended release capsule (162.5mg) formulation for ...[ Price : $8.95]
CVM announces fees for animal food and feed ingredients export certificates effective 10/1.[ Price : $8.95]
FDA clears a Royal Phillips 510(k) to market the Spectral Diagnostic Suite, a set of visualization and analysis tools designed for...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular...[ Price : $8.95]
Federal Register Notice: FDA corrects Web links for registration for a scientific workshop co-sponsored by FDA and the Coalition A...