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FDA tells BioMarin that it has not yet completed the review process for its NDA on Kyndrisa (drisapersen) and it will not take an ...[ Price : $8.95]
FDA approves a Torax Medical humanitarian device exemption for the Fenix Continence Restoration System to treat fecal incontinence...[ Price : $8.95]
FDA clears a GI Logic 510(k) for the AbStats System to be used by physicians in hospitals and other healthcare settings for real t...[ Price : $8.95]
Congress approves a budget and tax deal that will suspend the 2.3% medical device excise tax that has been in effect since 1/2013.[ Price : $8.95]
Pharmaceutical Research and Manufacturers of America and Pfizer comment on a draft guidance on Rare Diseases: Common Issues in Dru...[ Price : $8.95]
FDA clears a Luminex 510(k) for its NxTAG Respiratory Pathogen Panel that detects 20 clinically relevant viral and bacterial respi...[ Price : $8.95]
CDER requests demonstration projects to test the capability and evaluate performance of using an end-to-end Electronic Health Reco...[ Price : $8.95]
Federal Register Notice: FDA determines that regulatory review period Xtandi for the purpose of patent extension.