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GSK’s Nucala approved to treat chronic rhinosinusitis with nasal polyps
pharmatimes
August 02, 2021
GlaxoSmithKline’s (GSK) interleukin-5 (IL-5) inhibitor has received approval from the US Food and Drug Administration (FDA) for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP).
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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.
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NICE green light for GSK's Nucala
pharmatimes
February 05, 2021
GlaxoSmithKline's Nucala (mepolizumab) will be funded on the NHS in England and Wales for treating patients with severe eosinophilic asthma.
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FDA set to review GSK’s Nucala for nasal polyps
pharmatimes
December 11, 2020
The US Food and Drug Administration (FDA) is set to review GlaxoSmithKline’s (GSK) Nucala, after accepting a regulatory submission seeking approval for its use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
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New EU approval for GSK's Zejula
pharmatimes
November 04, 2020
GlaxoSmithKline's once-daily PARP inhibitor Zejula (niraparib) has been approved by the European Commission for first-line monotherapy maintenance treatment for adults with advanced ovarian cancer.
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FDA Approves First Drug to Treat Group of Rare Blood Disorders
americanpharmaceuticalreview
October 09, 2020
The U.S. Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the ...
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USFDA approves Nucala to treat hypereosinophilic syndrome
expresspharma
September 27, 2020
The approval granted to GlaxoSmithKline is the first approval for HES patients in nearly 14 years.
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FDA grants priority review of Nucala for patients with Hypereosinophilic Syndrome
pharmaceutical-business-review
May 29, 2020
GlaxoSmithKline (GSK) announced that the US Food and Drug Administration (FDA) has granted a priority review for the company’s application seeking approval of Nucala (mepolizumab) ...
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GSK’s asthma drug Nucala meets co-primary endpoints in SYNAPSE trial
pharmaceutical-business-review
April 08, 2020
GlaxoSmithKline (GSK) said that its asthma drug Nucala (mepolizumab) has succeeded in the phase 3 SYNAPSE trial in patients with nasal polyps associated with chronic rhinosinusitis (CRSwNP).
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GSK's Nucala shows promise in nasal polyps
pharmatimes
April 07, 2020
GlaxoSmithKline has reported positive late-stage data showing the benefit of its biologic Nucala (mepolizumab) in patients with nasal polyps in patient requiring further surgeries for the condition.