Drug Approval | April 17, 2024
GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA
Submission based on results from pivotal phase III trial showing all primary endpoints met
Submission based on results from pivotal phase III trial showing all primary endpoints met
Versavo is the first Dr. Reddy's biosimilar product to be approved and launched in the UK
The agreement licenses the company to launch in the United States, in February 2025, once approved by the U.S. FDA
Net product sales in the fourth quarter of 2023 include the recognition of $0.6 billion from deferred revenue, related to Gavi, the Vaccine Alliance
Submission to be reviewed under FDA real-time oncology review and Project Orbis
HIFU is a state-of-the-art treatment that utilizes high-frequency sound waves to target and destroy prostate cancer cells
Comprehensive clinical development programs being initiated for each investigational candidate
The company has received five final approvals
If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure
If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients
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