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FDA grants ReCor Medical a breakthrough device designation for Paradise Ultrasound Renal Denervation System and its use for treati...[ Price : $8.95]
FDA posts three new guidances for device makers to use under its Safety and Performance-Based Pathway.[ Price : $8.95]
FDA grants X4 Pharmaceuticals a rare pediatric disease designation for mavorixafor for treating WHIM (Warts, Hypogammaglobulinemia...[ Price : $8.95]
FDA accepts for filing an Atox Bio NDA for reltecimod to treat patients with necrotizing soft tissue infections.[ Price : $8.95]
Swedish researchers say they found no significant increase in the risk of death in patients who received paclitaxel-coated devices...[ Price : $8.95]
Federal Register notice: FDA withdraws the approval of an Allergan Pharmaceuticals International NDA for Asacol (mesalamine) delay...[ Price : $8.95]
Federal Register notice: FDA announces the names of the members who will serve on its fiscal year 2020 Performance Review Board.[ Price : $8.95]
The International Council on Harmonization says its electronic Common Technical Document question-and-answer document has reached ...