The United States Food and Drug Administration's(FDA's)August 2024 determination that an additional phase Ⅱ study will be required to consider the approval of midomafetamine for the treatment of posttraumatic...The United States Food and Drug Administration's(FDA's)August 2024 determination that an additional phase Ⅱ study will be required to consider the approval of midomafetamine for the treatment of posttraumatic stress disorder(PTSD)could delay the potential approval of this promising treatment by several years.展开更多
On November 3,2025,United Therapeutics Corporation(Nasdaq:UTHR)announced the first clinical xenotransplantation within its EXPAND study,involving transplantation of the UKidney into a patient with end‐stage renal dis...On November 3,2025,United Therapeutics Corporation(Nasdaq:UTHR)announced the first clinical xenotransplantation within its EXPAND study,involving transplantation of the UKidney into a patient with end‐stage renal disease(ESRD)at New York University(NYU)Langone Health.The UKidney is a genetically engineered porcine kidney incorporating 10 gene modifications-6 human gene insertions to enhance immunologic compatibility and 4 porcine gene knockouts to minimize rejection risk and control graft growth[1].In the context of the first xenotransplantation studies,“EXPAND”refers to the US Food and Drug Administration(FDA)“expanded access”program,often colloquially known as compassionate use.展开更多
文摘The United States Food and Drug Administration's(FDA's)August 2024 determination that an additional phase Ⅱ study will be required to consider the approval of midomafetamine for the treatment of posttraumatic stress disorder(PTSD)could delay the potential approval of this promising treatment by several years.
文摘On November 3,2025,United Therapeutics Corporation(Nasdaq:UTHR)announced the first clinical xenotransplantation within its EXPAND study,involving transplantation of the UKidney into a patient with end‐stage renal disease(ESRD)at New York University(NYU)Langone Health.The UKidney is a genetically engineered porcine kidney incorporating 10 gene modifications-6 human gene insertions to enhance immunologic compatibility and 4 porcine gene knockouts to minimize rejection risk and control graft growth[1].In the context of the first xenotransplantation studies,“EXPAND”refers to the US Food and Drug Administration(FDA)“expanded access”program,often colloquially known as compassionate use.
