Posts tagged Approbation
Incyte Announces Health Canada Approval of Minjuvi® (tafasitamab) in Combination with Lenalidomide for the Treatment of Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

MONTREAL, Aug. 24, 2021 /CNW/ - Incyte (Nasdaq: INCY) today announced that Health Canada has granted a Notice of Compliance with conditions for Minjuvi® (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, who are not eligible for autologous stem cell transplant (ASCT).

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Health Canada approves first-ever gene replacement therapy, Luxturna®

Novartis Pharmaceuticals Canada Inc. is pleased to announce that Health Canada has approved Luxturna® (voretigene neparvovec), a one-time gene therapy for the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells. The presence of biallelic RPE65 mutations should be confirmed by an accredited laboratory using validated assay methods.

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