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FDA seeks input 11/21 from its Cellular, Tissue, and Gene Therapies Advisory Committee about AstraZenecas Andexxa and an increased...[ Price : $8.95]
GSK says its Phase 3 GLISTEN trial evaluating linerixibat in adults with a relentless itch associated with primary biliary cholang...[ Price : $8.95]
FDA posts a draft guidance entitled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products.[ Price : $8.95]
FDA accepts for review an Aldeyra Therapeutics NDA for reproxalap, an investigational topical new drug candidate for treating sign...[ Price : $8.95]
FDA clears a BrightHeart 510(k) for its artificial intelligence software for reviewing prenatal ultrasound evaluations of the feta...[ Price : $8.95]
FDA issues Takeda Pharmaceutical a four-item Form FDA-483 after inspecting the firms Yamaguchi, Japan manufacturing facility and f...[ Price : $8.95]
Federal Register notice: FDA permanently debars Ivette Maria Portela Martinez from providing services to a person that has an appr...[ Price : $8.95]
Federal Register notice: FDA determines that Mercks Hydrocortone (hydrocortisone sodium phosphate) injection was not withdrawn due...