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FDA approves expanded age indication for Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk – GSK

Written by | 22 Jun 2024

GSK plc announced that the FDA has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50… read more.

New long-term data show Shingrix continues to provide high protection against shingles in adults aged 50 and over for more than a decade – GSK

Written by | 26 Apr 2024

GSK plc announced positive data from the ZOSTER-049 long-term follow-up phase III trial which followed participants for up to approximately 11 years following initial vaccination with Shingrix (Recombinant… read more.

Positive RUBY phase III data show potential for Jemperli (dostarlimab) combinations in more patients with primary advanced or recurrent endometrial cancer – GSK

Written by | 31 Mar 2024

GSK plc announced statistically significant and clinically meaningful overall survival (OS) results from Part 1 and progression-free survival (PFS) results from Part 2 of the RUBY/ENGOTEN6/GOG3031/NSGO phase III… read more.

Shingrix for the prevention of shingles in at-risk adults aged 18 and over is accepted for review by China National Medical Products Administration – GSK

Written by | 16 Feb 2024

GSK plc announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted for review the regulatory application of Shingrix (Recombinant… read more.

Arexvy is accepted under Priority Review in US for the prevention of RSV disease in adults aged 50-59 at increased risk – GSK

Written by | 14 Feb 2024

GSK plc announced that the FDA has accepted under priority review an application to extend the indication of GSK’s adjuvanted respiratory syncytial virus (RSV) vaccine to adults aged… read more.

Positive results from DREAMM-7 head-to-head phase III trial for Blenrep (belantamab mafodotin) in relapsed/refractory multiple myeloma – GSK

Written by | 3 Dec 2023

GSK plc announced positive headline results from a planned interim efficacy analysis of the DREAMM-7 head-to-head phase III trial evaluating belantamab mafodotin as a second-line treatment for relapsed… read more.

GSK announces major step towards sustainability ambitions with advancement of low carbon Ventolin programme to Phase III trials

Written by | 25 Nov 2023

GSK plc announced it will start Phase III trials of a low carbon version of its metered dose inhaler (MDI), Ventolin (salbutamol), using a next generation propellant, in… read more.

CHMP positive for Omjjara (momelotinib) to treat myelofibrosis – GSK

Written by | 14 Nov 2023

On 9 November 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product… read more.

National Medical Products Administration has approved for Vocabria (cabotegravir) in combination with Rekambys (rilpivirine), the first and only complete long-acting HIV-1 injectable treatment – Viiv HealthCare

Written by | 13 Nov 2023

GSK plc has announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders announced that the National Medical Products… read more.

MHRA (UK) approves Jemperli (dostarlimab), a treatment for some types of endometrial cancer in adults – GSK

Written by | 11 Oct 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised a new indication for Jemperli (dostarlimab), a treatment for some types of endometrial cancer in adults. It can… read more.

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.

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