Johnson & Johnson says it is pausing the limited U.S. rollout of its new Varipulse ablation technology while it investigates the root cause of four pa...
FDA grants Alleviant Medical a breakthrough designation for its no-implant atrial shunt technology for treating heart failure with reduced ejection fr...
Three RebootRx executives call on FDA to create a labeling-only 505(b)(2) NDA pathway to allow non-manufacturers to seek approval for repurposed gener...
Federal Register notice: FDA makes available a draft guidance entitled Developing Drugs for Optical Imaging.
Federal Register notice: FDA makes available a draft guidance entitled Obesity and Overweight: Developing Drugs and Biological Products for Weight Red...
FDA publishes one draft general and five specific immediately effective guidances to help establishments understand regulations governing donor eligib...
FDA grants a priority review for a Verastem Oncology NDA for avutometinib, an oral RAF/MEK clamp for use in combination with defactinib for treating c...
FDA says voluntary submission of clinical study diversity action plans increased from FY 2023 to FY 2024.
