Federal Register notice: FDA makes available a final guidance entitled Human Gene Therapy Products Incorporating Human Genome Editing.
Federal Register notice: FDA makes available a final guidance entitled Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Pr...
Federal Register notice: FDA makes available a draft guidance entitled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies f...
FDA lifts a 2022-imposed clinical hold against INmune Bios XPro (XPro1595; pegipanermin) and its Alzheimers disease clinical trial.
Bloomberg Law says the Justice Department is looking into the use of AI in electronic health records to push doctors to prescribe particular treatment...
FDA accepts for priority review an AstraZeneca and Daiichi Sankyo supplemental BLA for Enhertu (trastuzumab deruxtecan) for treating adult patients wi...
Some 29 advocacy groups call on FDA to act quickly to finalize a ban on electric skin shock devices used to treat self-injurious or aggressive behavio...
FDA warns Thailands S&J International Enterprises about CGMP violations in its production of finished drugs and refusing to allow some records to be c...