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The Taxpayers Protection Alliance calls on FDA to make changes in its regulation of drugs, tobacco, and foods to promote innovatio...[ Price : $8.95]
FDA announces availability of a technical specifications guidance with bioanalytical methods templates.[ Price : $8.95]
FDA approves Gilead Sciences Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for use in certain at-risk adults and ...[ Price : $8.95]
Nippon Shinyaku completes submission of a rolling NDA for viltolarsen, a Duchenne muscular disease drug that is amenable to exon 5...[ Price : $8.95]
FDA clears a Biofourmis 510(k) for its machine-learning and artificial intelligence-powered Biovitals Analytics Engine as a medica...[ Price : $8.95]
Federal Register notice: FDA corrects a 6/4 Federal Register notice withdrawing approval of five ANDAs for pemoline products becau...[ Price : $8.95]
FDA denies a Zydus petition asking it to take certain actions regarding new applications citing Mephyton as the reference-listed-d...[ Price : $8.95]
FDA grants Verastem an orphan drug designation for Copiktra (duvelisib) for use in treating T-Cell lymphoma.