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Federal Register notice: FDA makes available a final guidance entitled Human Gene Therapy Products Incorporating Human Genome Edit...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Considerations for the Development of Chimeric Antigen Rece...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Collection of Race and Ethnicity Data in Clinical Trials an...[ Price : $8.95]
FDA lifts a 2022-imposed clinical hold against INmune Bios XPro (XPro1595; pegipanermin) and its Alzheimers disease clinical trial...[ Price : $8.95]
Bloomberg Law says the Justice Department is looking into the use of AI in electronic health records to push doctors to prescribe ...[ Price : $8.95]
FDA accepts for priority review an AstraZeneca and Daiichi Sankyo supplemental BLA for Enhertu (trastuzumab deruxtecan) for treati...[ Price : $8.95]
Some 29 advocacy groups call on FDA to act quickly to finalize a ban on electric skin shock devices used to treat self-injurious o...[ Price : $8.95]
FDA warns Thailands S&J International Enterprises about CGMP violations in its production of finished drugs and refusing to allow ...