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