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FDA grants Alleviant Medical a breakthrough designation for its no-implant atrial shunt technology for treating heart failure with...[ Price : $8.95]
Three RebootRx executives call on FDA to create a labeling-only 505(b)(2) NDA pathway to allow non-manufacturers to seek approval ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Developing Drugs for Optical Imaging.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Obesity and Overweight: Developing Drugs and Biological Pro...[ Price : $8.95]
FDA publishes one draft general and five specific immediately effective guidances to help establishments understand regulations go...[ Price : $8.95]
FDA grants a priority review for a Verastem Oncology NDA for avutometinib, an oral RAF/MEK clamp for use in combination with defac...[ Price : $8.95]
FDA says voluntary submission of clinical study diversity action plans increased from FY 2023 to FY 2024.[ Price : $8.95]
FDA warns Austin, TX-based XO Biologix that it is marketing an unapproved adulterated and misbranded product derived from amniotic...