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Ojjaara (momelotinib) approved by FDA to treat intermediate or high-risk myelofibrosis – GSK

Written by | 20 Sep 2023

GSK plc announced that the FDA has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential… read more.

MHLW (Japan) accepts for review application for Nucala to treat chronic rhinosinusitis with nasal polyps – GSK

Written by | 11 Sep 2023

GSK plc announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has accepted for review a supplementary new drug application (sJNDA) for Nucala (mepolizumab), a monoclonal… read more.

Results of phase IV trial (ZOSTER-076) of Shingrix shows efficacy and safety in Herpes Zoster – GSK

Written by | 31 Aug 2023

GSK announced positive results from the first-ever efficacy trial of Shingrix (Recombinant Zoster Vaccine or RZV) in China. These results come from the post-license phase IV trial (ZOSTER-076),… read more.

Jemperli + chemotherapy approved by the FDA as the first new frontline treatment option in decades for dMMR/MSI-H primary advanced or recurrent endometrial cancer – GSK

Written by | 3 Aug 2023

GSK plc announced that the FDA has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult… read more.

MHRA (UK) approves Arexvy for prevention of lower respiratory tract disease caused by respiratory syncytial virus in adults 60 years of age and older – GSK

Written by | 19 Jul 2023

GSK plc announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower… read more.

MLHW (Japan) approves updated indication for Shingrix for the prevention of Shingles – GSK

Written by | 14 Jul 2023

GSK plc announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved an updated indication for Shingrix (Recombinant Zoster Vaccine, Adjuvanted – RZV) for the… read more.

CHMP positive for Jesduvroq to treat symptomatic anemia in adults with chronic kidney disease who are on dialysis – GSK

Written by | 7 Jul 2023

Jesduvroq (daprodustat) from GSK received a positive opinion from the CHMP for the treatment of adult patients for for the treatment of symptomatic anaemia in adults with chronic… read more.

EU approves Arexvy for respiratory syncytial virus – GSK

Written by | 11 Jun 2023

GSK announced that the European Commission has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by… read more.

Positive results from phase III PRIME study of Zejula at Society of Gynecologic Oncology Meeting – Zai Lab + GSK

Written by | 7 Jul 2022

Zai Lab Limited presented data from the Phase III PRIME study of Zejula (niraparib) as maintenance therapy at the Society of Gynecologic Oncology annual meeting . Zejula demonstrated… read more.

GSK position regarding the acquisition of Vectura by Philip Morris International (PMI)

Written by | 16 Sep 2021

Following the news of the acquisition of Vectura by Philip Morris International (PMI), we would like to clarify GSK’s position regarding Ellipta inhalers and their association with Vectura.

GSK announces positive headline results from five phase III studies of daprodustat for patients with anaemia due to chronic kidney disease

Written by | 28 Jul 2021

GlaxoSmithKline plc announced positive headline results from five studies of the Phase III ASCEND programme, evaluating the efficacy and safety profile of daprodustat, an investigational oral hypoxia-inducible factor… read more.

European Commission approves Benlysta for adult patients with active lupus nephritis – GSK

Written by | 13 May 2021

GlaxoSmithKline plc announced the European Commission has approved the expanded use of intravenous and subcutaneous Benlysta (belimumab) in combination with background immunosuppressive therapies for the treatment of adult… read more.

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