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 Regulatory

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
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