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Federal Register notice: FDA announces a 3/19/18 public workshop entitled Patient-Focused Drug Development: Developing and Submitt...[ Price : $8.95]
The Federal Circuit Court of Appeals rules against Amgen in the continuing dispute between it and Sandoz over application of provi...[ Price : $8.95]
An updated FDA assessment says the agency continues to caution against using laparoscopic power morcellators to treat presumed ute...[ Price : $8.95]
FDA releases the FDA-483 issued after a 2014 inspection at Baxter Healthcare.[ Price : $8.95]
FDA clears a Chemence Medical 510(k) to market and sell Exofin Fusion, a new skin closure system for medium to large wounds.[ Price : $8.95]
HHS lists drug and medical device regulatory priorities for FDA.[ Price : $8.95]
FDA clears a Gel-e Inc. 510(k) for its adhesive bandage for prescription and over-the-counter use in managing moderately to heavil...[ Price : $8.95]
FDA accepts a Bristol-Myers Squibb supplemental BLA for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat in...