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Takeda Presents Positive Results from Phase 3 Study of Vedolizumab for Prevention of Intestinal Acute Graft-Versus-Host Disease (aGvHD) in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)

The Phase 3 GRAPHITE Study Met Its Primary Efficacy Endpoint of Significant and Clinically Meaningful Intestinal aGvHD-Free Survival as Compared to Placebo by Day 180 after Allo-HSCT No New... | February 18, 2023
United States Bin Chen John Cunningham Cancer Center International Blood Marrow Transplant Research Hematopoietic Cell Transplant Therapy Program

Takeda Presents Positive Results from Phase 3 Study of Vedolizumab for Prevention of Intestinal Acut

The Phase 3 GRAPHITE Study Met Its Primary Efficacy Endpoint of Significant and Clinically Meaningful Intestinal aGvHD-Free Survival as Compared to Placebo by Day 180 after Allo-HSCT (pNo New Safety Signals Were Seen with Vedolizumab Compared with Placebo in Patients Who Received Allo-HSCTData Were Presented as A La...
United States Bin Chen John Cunningham Jun Saito Cancer Center International Blood Marrow Transplant Research

Guerbet Announces Commercial Launch and First Patient Dosing of Elucirem™ (Gadopiclenol) Injection, a Novel New Macrocyclic GBCA for Use in Contrast-Enhanced Magnetic Resonance Imaging (MRI)

/PRNewswire/ -- Guerbet, a global leader in medical imaging with more than 30 years of experience in MRI, announced today the commercial launch and dosing of...
University Of Pennsylvania United States North Carolina Lauriea Loevner Leeann Essai Edie Elkinson

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FDA Approval Mifepristone REMS Program Modification Expands Patient Access to Abortion Care | Sheppard Mullin Richter & Hampton LLP

The Food and Drug Administration (the “FDA”) has approved a modification to the Mifepristone Risk Evaluation and Mitigation Strategy (“REMS”) Program, increasing the accessibility of...
United States Jackson Women Health Organization Drug Administration Sheppard Mullin Richter Hampton Maryland Us District Court Us Supreme Court

FDA Approves Changes to REMS Program

The FDA approved a modification to the Mifepristone Risk Evaluation and Mitigation Strategy, REMS, Program. The FDA’s approval of commercial dispensing of mifepristone likely will not change the current practice of prescribing and dispensing mifepristone for abortion.
United States Jackson Women Health Organization Drug Administration Maryland Us District Court Us Supreme Court American College Of Obstetricians

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