GSK expands RSV vaccine to younger adults in US, targeting high-risk 18–49 age group
Previously, Arexvy was authorized for adults 60 and older, and for those 50–59 with heightened risk
Previously, Arexvy was authorized for adults 60 and older, and for those 50–59 with heightened risk
The move comes as China rapidly expands its capabilities in the pharmaceutical sector, particularly in licensing and drug development
The Phase 2 trial, conducted through Starton’s Sargon Site Network, is expanding from two to six sites across the U.S.
BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data
Both non-transfusion-dependent and transfusion dependent cohorts met their respective primary and secondary endpoints
The drug’s safety profile in LIBRETTO-432 aligned with previous selpercatinib studies, showing no unexpected concerns
The designation for HCB101covers all forms of gastric cancer, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative patients
The recommendation is based on new data from continuous safety monitoring of medicines in the EU
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