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Benlysta News

FDA Approves Benlysta Autoinjector for Pediatric Patients With Active Lupus Nephritis

MONDAY, June 30, 2025 – The U.S. Food and Drug Administration has approved an autoinjector of Benlysta (belimumab) for subcutaneous injection in patients ≥5 years of age with active lupus nephritis w...

FDA Approves Benlysta (belimumab) Autoinjector for Children with Active Lupus Nephritis

Philadelphia, PA June 24 2025 – GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a 200 mg/mL autoinjector of Benlysta (belimumab), a B-lymphocyte ...

FDA Approves Benlysta (belimumab) Autoinjector for Children with Systemic Lupus Erythematosus

Philadelphia, PA May 20 2024 – GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a 200 mg subcutaneous route of administration of Benlysta...

GSK Announces US FDA Approval of Benlysta (belimumab) for Pediatric Patients with Active Lupus Nephritis

Benlysta is now the first and only biologic approved for adults and children who have lupus or lupus nephritis London UK 27 July 2022 – GSK plc (LSE/NYSE: GSK) today announced that the US Food and...

FDA Approves GSK’s Benlysta as the First Medicine for Adult Patients with Active Lupus Nephritis in the US

17 December 2020 --  GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved Benlysta (belimumab) for the treatment of adult patients with active lupus ...

GSK Receives US Approval of Benlysta for Intravenous Use in Children with Lupus Aged Five Years and Above

London UK, Philadelphia USA April 26, 2019 – GSK today announced that the US Food and Drug Administration (FDA) has approved, under priority review, the use of the intravenous (IV) formulation of...

GSK Receives FDA Approval for a New Self-Injectable Formulation of Benlysta (belimumab) for Systemic Lupus Erythematosus

London, UK 21 July 2017 – GSK announced today that the US Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Benlysta (belimumab) for the treatment of adult patients...

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Systemic Lupus Erythematosus

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