FDA grants Genea Biocells an orphan drug designation for GBC0905 and its use in treating facioscapulohumeral muscular dystrophy.
FDA releases a draft guidance to help sponsors with the premarket assessment of a drugs effect on blood pressure.
FDA publishes an International Conference on Harmonization draft guidance on technical and regulatory considerations for drug product lifecycle manage...
FDA releases a draft guidance listing relevant information the agency wants included in complete test reports for non-clinical bench performance testi...
FDA releases the FDA-483 with 11 observations from a Zimmer Biomet inspection.
FDA clears a Neural Analytics 510(k) for its NeuralBot System, a robotic assistance technology which automatically adjusts orientation and position of...
FDA expands the approval of Pfizers Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis.
Federal Register notice: FDA seeks comments on an information collection extension for its Guidance for Clinical Trial Sponsors: Establishment and Ope...