FDA: More Data on Remestemcel-L for Graft Versus Host Disease Needed
In the CRL, the FDA recommended that the Company conduct at least 1 additional randomized, clinical study.
In the CRL, the FDA recommended that the Company conduct at least 1 additional randomized, clinical study.
The BLA submission includes data from a phase 3 study comparing inolimomab to antithymocyte globulin in 100 adults with steroid-refractory aGvHD.
The FDA has granted Orphan Drug Designation to Tacrolimus Inhalation Powder (TFF Pharmaceuticals) for prophylaxis of lung allograft rejection.
The FDA has accepted for Priority Review the Biologics License Application for remestemcel-L (RyoncilTM; Mesoblast Limited) for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).
Certain blister packages of Sandimmune (cyclosporine capsules) and Neoral (cyclosporine capsules) may not meet child-resistant packaging requirements, according to manufacturer Novartis. The Company announced that it is working with the Consumer Product Safety Commission to address the packaging issue. In a press statement, Novartis stressed that there are no quality or efficacy issues with the…
No antibody induction therapy with sirolimus plus tacrolimus associated with maximal survival
The FDA has approved Jakafi (ruxolitinib; Incyte) for treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients ≥12 years old.
Veloxis announced that the Food and Drug Administration (FDA) has approved Envarsus XR (tacrolimus extended-release) tablets to prevent organ rejection in de novo kidney transplant patients in combination with other immunosuppressants.
The designation was granted to Revive Therapeutics, a company that specializes in cannabis-based pharmaceuticals.
Of the 5256 patients who received a renal transplant in the study window (1/1/1998 – 12/31/2017), 14 met inclusion criteria.