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NICE backs GSK’s Zejula in advanced ovarian cancer pharmatimes
January 18, 2021
The UK’s National Institute for Health and Care Excellence (NICE) has recommended the use of GlaxoSmithKline’s Zejula (niraparib) on the NHS for women with newly diagnosed advanced ovarian cancer.
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.
GSK’s Zejula and AZ’s Lynparza leap toward broader EU approval pharmatimes
September 23, 2020
GlaxoSmithKline’s Zejula and AstraZeneca’s Lynparza have both moved towards EU approval in new indications after receiving positive opinions from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
GSK books 19% sales growth for first quarter pharmatimes
May 05, 2020
GlaxoSmithKline has reported 19% growth in group sales to £9.1 billion for the first quarter.
FDA accepts Zejula sNDA application as a maintenance treatment for ovarian cancer europeanpharmaceuticalreview
March 04, 2020
The developers of Zejula (niraparib) have announced the FDA will assess the sNDA application under the Real-Time Oncology Review (RTOR) pilot programme.
European Medicines Agency accepts submission of GSK's Marketing Authorisation Application for Zejula (niraparib) in first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer prnasia
February 29, 2020
GlaxoSmithKline plc announced that the European Medicines Agency (EMA) has validated the company's Type II Variation (T2V) for Zejula (niraparib) as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to
Zai Lab Announces NMPA Approval of ZEJULA in China americanpharmaceuticalreview
January 02, 2020
Zai Lab announced the China National Medical Products Administration (NMPA) approved the New Drug Application (NDA) for ZEJULA (niraparib) ...
Thorny path: A replay of how Tesaro got its $5.1B GlaxoSmithKline buyout fiercepharma
December 18, 2018
With its Tesaro buyout, GlaxoSmithKline CEO Emma Walmsley finally beefed up in oncology, one of the fields she tagged for growth about a year ago. For the small biotech, the sale marked the end of a longer and more arduous journey.
GlaxoSmithKline to buy Tesaro for $5.1 billion, gaining PARP inhibitor Zejula firstwordpharma
December 03, 2018
GlaxoSmithKline announced Monday an agreement to acquire Tesaro for around $5.1 billion in cash, gaining the latter's oral PARP inhibitor Zejula (niraparib). GlaxoSmithKline CEO Emma Walmsley said the deal "will strengthen our pharmaceuticals business by
GlaxoSmithKline to buy Tesaro for $5.1 billion, gaining PARP inhibitor Zejula firstwordpharma
December 03, 2018
GlaxoSmithKline announced Monday an agreement to acquire Tesaro for around $5.1 billion in cash, gaining the latter's oral PARP inhibitor Zejula (niraparib). GlaxoSmithKline CEO Emma Walmsley said the deal "will strengthen our pharmaceuticals business by

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