Novavax's Nuvaxovid receives full marketing authorization in the EU
Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU
Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU
This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
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
Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.
CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%
First PARP inhibitor and new hormonal agent combination approved for these patients in Europe
Positive opinions based on significant survival benefit
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