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FDA approves an Amgen NDA for Repatha (evolocumab) injection for certain patients who are unable to get their low-density lipoprot...[ Price : $8.95]
FDA obliquely deflects Congressional suspicions that it has used the timing of regulatory letter Web postings to punish recipient ...[ Price : $8.95]
Rothman Institute of Innovation and Entrepreneurship executive director Joseph Gulfo lists four substantive changes he wants to se...[ Price : $8.95]
FDA tells a House committee that it believes that mandatory prescriber education is an important element in effectiveness of REMS ...[ Price : $8.95]
Elite Biomedical Solutions recalls its Alaris Medley LVP Frame Membrane that is used with the Alaris Medley 8100 infusion pump, ci...[ Price : $8.95]
A just-released FDA-483 lists five violations found in an agency inspection at Fujifilm Medical Systems.[ Price : $8.95]
FDA grants Symbiomix fast track status for SYM-1219, which is a single-dose, oral product candidate for treating bacterial vaginos...[ Price : $8.95]
Federal Register Notice: FDA determines that AbbVies Biaxin XL tablets were not withdrawn from sale for reasons of safety or effec...