FDA issues a partial clinical hold on a BioNTech and OncoC4, Phase 3 trial that is assessing gotistobart in non-small cell lung cancer.
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.
FDA publishes a guidance outlining a framework for considering the types of long-term neurodevelopmental safety studies that could support a determina...
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FDA posts a draft guidance entitled Postoperative Nausea and Vomiting: Developing Drugs for Prevention.
