FDA says it is continuing to review the sNDA submitted by Intercept Pharmaceuticals for its Ocaliva following an advisory committee 10-1 vote not to r...
FDA approves an AbbVie NDA for Vyalev (foscarbidopa and foslevodopa), a subcutaneous 24-hour infusion of levodopa-based therapy for treating advanced ...
FDA posts a draft guidance entitled Postoperative Nausea and Vomiting: Developing Drugs for Prevention.
Federal Register notice: FDA extends the comment period on a 9/23 notice about three draft guidance documents related to CDRHs Accreditation Scheme fo...
Attorney Deborah Livornese says FDA wants user feedback on the NDA integrated review format it has been publishing for several years.
Federal Register notice: FDA makes available a final guidance requesting the reconsideration of an ANDA decision at the division level.
Staska Pharmaceuticals recalls one lot of ascorbic acid solution for injection (500mg/mL, 50mL vials) due to the presence of glass particulates in som...
FDA publishes a guidance with recommendations for collecting a core set of patient-reported clinical outcomes in cancer clinical trials.
