Wockhardt’s WCK 5222 earns accelerated review from European Medicines Agency
The accelerated review covers WCK 5222 for multiple critical infections
The accelerated review covers WCK 5222 for multiple critical infections
Decision on EU marketing authorisation for this population expected by September 2024
Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union
Heavy bleeding after giving birth is globally a leading cause of death in new mothers
Notice of Compliance from Health Canada enables marketing authorisation for cancer biosimilar in Canadian market
The twin designations are designed to speed up the development and review of promising medicines targeting serious conditions with high unmet need
The approval, following a positive recommendation from the European Medicines Agency’s CHMP, makes the vaccine valid across all 27 EU member states
Novo Nordisk continues to position Wegovy as a cornerstone of its obesity treatment portfolio
Chronic GVHD is a serious and potentially life-threatening condition, imposing profound physical and emotional burdens on a substantial proportion of patients following allogeneic stem cell transplantation
The approach, which could significantly reduce the number of rats used in certain dose-range finding studies
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