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Federal Register notice: FDA makes available a draft guidance entitled Developing Drugs for Optical Imaging.
Federal Register notice: FDA makes available a draft guidance entitled Obesity and Overweight: Developing Drugs and Biological Products for Weight Red...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.
FDA warns Austin, TX-based XO Biologix that it is marketing an unapproved adulterated and misbranded product derived from amniotic fluid.
