Drug Approval | June 08, 2023
European Commission authorises GSK’s Arexvy for older adults
Authorisation will help protect adults 60 years of age and older in 30 European countries* from RSV disease for the first time
Authorisation will help protect adults 60 years of age and older in 30 European countries* from RSV disease for the first time
Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphoma
mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 44% compared to KEYTRUDA alone in stage III/IV melanoma patients
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial and unmet need for additional therapeutic options for certain types of melanoma
NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China
Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.
This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.
Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
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