GSK
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GSK launches Shingrix in South Africa following SAHPRA registration
The vaccine was registered earlier this month by the South African Health Products Regulatory Authority (SAHPRA), paving the way for large-scale importation and commercial distribution.
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GSK-Spero Therapeutics’ Utebzi earns FDA approval to combat rising global antimicrobial resistance
More than 3 million cases of complicated UTIs are recorded annually in the United States, and treatment failure affects up to one-third of patients.
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GSK strikes US$10.6B Nuvalent deal to strengthen lung cancer pipeline
The acquisition comes as GSK intensifies its shift toward oncology to offset expected revenue pressure from upcoming patent expirations in its HIV franchise.
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GSK expands China footprint through Sino Biopharmaceutical partnership for Hepatitis B therapy bepirovirsen
CTTQ will also purchase a supply of bepirovirsen for an initial period of five and a half years, while GSK will record product sales from the arrangement, though the companies are not disclosing the financial value of the deal.
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GSK bets US$1B on SiranBio’s ALK7 siRNA to disrupt the obesity market
The agreement excludes China, Hong Kong, Macau, and Taiwan, where SiranBio will retain rights.
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GSK’s Efimosfermin receives dual fast-track designations for MASH treatment
The US Food and Drug Administration granted the therapy Breakthrough Therapy Designation, while the European Medicines Agency awarded it Priority Medicines status.
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GSK’s Exdensur secures NMPA approval in China for chronic rhinosinusitis
The medication works as an add-on therapy alongside intranasal corticosteroids for patients whose condition fails to respond adequately to systemic corticosteroids or surgical intervention.
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GSK’s Bepirovirsen under EMA review for chronic hepatitis B
Chronic hepatitis B affects an estimated 3.2 million people in Europe alone and more than 250 million people globally.
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GSK to support UK meningitis B vaccine expansion following Kent outbreak
The UK Health Security Agency (UKHSA) has launched a targeted vaccination programme, beginning with students residing at the University of Kent.
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FDA expands GSK’s Arexvy approval to high-risk adults aged 18-49
The FDA based its approval decision on data from a global Phase IIIb clinical trial demonstrating Arexvy’s effectiveness in the younger adult population.