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GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps firstwordpharma
July 30, 2021
GlaxoSmithKline plc (GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps.
FDA Approves Nucala (mepolizumab) for Six to 11-Year-Old Children with Severe Eosinophilic Asthma drugs
September 16, 2019
GlaxoSmithKline today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for use in children as young as six years old who are living with severe eosinophilic asthma.
Nucala (mepolizumab) gains FDA approval for two new self-administration options worldpharmanews
June 10, 2019
Nucala (mepolizumab) gains FDA approval for two new self-administration options.
GSK Receives CRL from FDA for Mepolizumab americanpharmaceuticalreview
September 11, 2018
GlaxoSmithKline received a complete response letter (CRL) from the FDA regarding its application for mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstr
FDA staff question efficacy of GSK’s Nucala for COPD pharmatimes
July 25, 2018
US regulatory advisors are questioning the effectiveness of GlaxoSmithKline’s biologic Nucala as a treatment for patients experiencing a sudden worsening of chronic obstructive pulmonary disorder (COPD).