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Positive Opinion

Amgen's Lumykras (sotorasib) Receives CHMP's Positive Opinion for the Treatment of KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer

Amgen's Lumykras (sotorasib) Receives CHMP's Positive Opinion for the Treatment of KRAS G12C-Mutated Advanced Non-Small Cell Lung...

  • November 15, 2021
Celltrion's CT-P59 (regdanvimab) Receives CHMP's Positive Opinion for the Treatment of COVID-19

Celltrion's CT-P59 (regdanvimab) Receives CHMP's Positive Opinion for the Treatment of COVID-19

  • November 12, 2021
AbbVie-Skyrizi (risankizumab) Receives CHMP's Positive Opinion for the Treatment of Adults with Active Psoriatic Arthritis in the EU

AbbVie-Skyrizi (risankizumab) Receives CHMP's Positive Opinion for the Treatment of Adults with Active Psoriatic Arthritis in the...

  • October 18, 2021
Bristol Myers Squibb's Zeposia (ozanimod) Receives CHMP's Positive Opinion for Adult Patients with Moderately to Severely Active Ulcerative Colitis

Bristol Myers Squibb's Zeposia (ozanimod) Receives CHMP's Positive Opinion for Adult Patients with Moderately to Severely Active U...

  • October 15, 2021
Sanofi's Avalglucosidase alfa Receives CHMP's Positive Opinion for Patients with Pompe Disease

Sanofi's Avalglucosidase alfa Receives CHMP's Positive Opinion for Patients with Pompe Disease

  • July 28, 2021
Alexion's Ultomiris (ravulizumab) Receives CHMP's Positive Opinion Recommending its Approval for Children and Adolescents with PNH

Alexion's Ultomiris (ravulizumab) Receives CHMP's Positive Opinion Recommending its Approval for Children and Adolescents with PNH

  • July 26, 2021
BeiGene Reports the CHMP’s Positive Opinions for Tevimbra as a 1L Treatment of G/GEJ Cancer and Esophageal Squamous Cell Carcinoma

    BeiGene Reports the CHMP’s Positive Opinions for Tevimbra as a 1L Treatment of G/GEJ Cancer and Esophageal Squamous Cell Carcinoma

    • October 22, 2024
    AstraZeneca and Ionis’ Wainzua (Eplontersen) Receives the CHMP’s Positive Opinion to Treat Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy

      AstraZeneca and Ionis’ Wainzua (Eplontersen) Receives the CHMP’s Positive Opinion to Treat Hereditary Transthyretin-Mediated Amylo...

      • October 21, 2024
      Novartis’ Kisqali (Ribociclib) Gains the CHMP’s Positive Opinion as an Adjuvant Treatment of HR+/HER2- Early Breast Cancer (EBC)

        Novartis’ Kisqali (Ribociclib) Gains the CHMP’s Positive Opinion as an Adjuvant Treatment of HR+/HER2- Early Breast Cancer (EBC)

        • October 18, 2024
        GSK Reports the CHMP’s Positive Opinion of Menveo Vaccine Against Invasive Meningococcal Disease

          GSK Reports the CHMP’s Positive Opinion of Menveo Vaccine Against Invasive Meningococcal Disease

          • September 24, 2024
          AstraZeneca’s Fasenra Receives the CHMP’s Positive Opinion for Treating Eosinophilic Granulomatosis with Polyangiitis

            AstraZeneca’s Fasenra Receives the CHMP’s Positive Opinion for Treating Eosinophilic Granulomatosis with Polyangiitis

            • September 24, 2024
            The CHMP Grants Positive Opinion to Samsung Bioepis and Biogen’s Opuviz (Biosimilar, Eylea)

              The CHMP Grants Positive Opinion to Samsung Bioepis and Biogen’s Opuviz (Biosimilar, Eylea)

              • September 23, 2024
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