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FDA posts a draft guidance entitled Postoperative Nausea and Vomiting: Developing Drugs for Prevention.
Federal Register notice: FDA extends the comment period on a 9/23 notice about three draft guidance documents related to CDRHs Accreditation Scheme fo...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.
FDA places a clinical hold on the Novavax IND for a Covid-19/influenza combination vaccine and influenza standalone vaccine following a report of one ...
FDA publishes a guidance reflecting GDUFA 3 provisions on the procedures for ANDA applicants to follow in requesting reconsideration of scientific iss...
FDA clears a Bracco Diagnostics and Subtle Medical 510(k) for their artificial intelligence-powered software AiMify for brain MRIs.
