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 Regulatory

PharmaShots Weekly Snapshots (March 31, 2025 – April 04, 2025)

PharmaShots Weekly Snapshots (March 31, 2025 – April 04, 2025)

  • April 4, 2025
AstraZeneca Reports the EC’s Approval of Imfinzi Regimen as Perioperative Treatment of NSCLC

AstraZeneca Reports the EC’s Approval of Imfinzi Regimen as Perioperative Treatment of NSCLC

  • April 4, 2025
Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

  • April 4, 2025
Amgen’s Uplizna Receives the US FDA’s Approval for Immunoglobulin G4-related Disease (IgG4-RD)

Amgen’s Uplizna Receives the US FDA’s Approval for Immunoglobulin G4-related Disease (IgG4-RD)

  • April 4, 2025
Novartis’ Vanrafia (Atrasentan) Receives the US FDA’s Accelerated Approval for Primary IgA Nephropathy (IgAN)

Novartis’ Vanrafia (Atrasentan) Receives the US FDA’s Accelerated Approval for Primary IgA Nephropathy (IgAN)

  • April 3, 2025
Averoa Receives the CHMP’s Positive Opinion for Xoanacyl to Treat Chronic Kidney Disease

Averoa Receives the CHMP’s Positive Opinion for Xoanacyl to Treat Chronic Kidney Disease

  • April 2, 2025
Apellis Pharmaceuticals Reports the US FDA’s sNDA Acceptance & Priority Review of Empaveli for C3G and Primary IC-MPGN

    Apellis Pharmaceuticals Reports the US FDA’s sNDA Acceptance & Priority Review of Empaveli for C3G and Primary IC-MPGN

    • April 2, 2025
    Pfizer Secures the EC’s Approval for Abrysvo (Respiratory Syncytial Virus Vaccine) for RSV Lower Respiratory Tract Disease

      Pfizer Secures the EC’s Approval for Abrysvo (Respiratory Syncytial Virus Vaccine) for RSV Lower Respiratory Tract Disease

      • April 1, 2025
      Alnylam Pharmaceuticals and Sanofi Report the US FDA’s Approval of Qfitlia (Fitusiran) to Treat Hemophilia A or B

        Alnylam Pharmaceuticals and Sanofi Report the US FDA’s Approval of Qfitlia (Fitusiran) to Treat Hemophilia A or B

        • April 1, 2025
        Genmab and Pfizer Secure the EC’s Approval for Tivdak (Tisotumab Vedotin) for Recurrent or Metastatic Cervical Cancer

          Genmab and Pfizer Secure the EC’s Approval for Tivdak (Tisotumab Vedotin) for Recurrent or Metastatic Cervical Cancer

          • April 1, 2025
          AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Receives the CHMP’s Positive Opinion for 1L Mantle Cell Lymphoma (MCL)

            AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Receives the CHMP’s Positive Opinion for 1L Mantle Cell Lymphoma (...

            • March 31, 2025
            BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC

              BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC

              • March 31, 2025
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