Janssen Pharmaceutical discontines, due to futility, its Phase 3 MACiTEPH study evaluating macitentan 75 mg in patients with chronic thromboembolic pu...
CymaBay Therapeutics says it will seek FDA approval for seladelpar for treating adult patients with primary biliary cholangitis after reporting Phase ...
Federal Register notices: FDA issues two priority review vouchers to sponsors whose recent product approvals met the criteria (rare pediatric disease ...
FDA says it is working with the CDC to investigate cases of TB associated with a bone matrix product.
Federal Register notice: FDA releases three draft guidances that are intended to improve the predictability, consistency, and transparency of the 510(...
Federal Register notice: FDA announces a 10/31 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to review a Vertex Pharmaceuticals BLA ...
FDA publishes a guidance with questions and answers on applying human factors engineering principles in developing combination drug products.
Four stakeholder groups suggest revisions to an FDA publication of the ICH E6(R3) good clinical practice guideline.
