If approved, Blenrep (belantamab mafodotin) in combinations with BorDex (BVd) and PomDex (BPd) could redefine multiple myeloma treatment at or after first relapse
HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors
Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years
Statistically significant and clinically meaningful reduction in the risk of death seen with Blenrep (belantamab mafodotin) plus bortezomib and dexamethasone (BorDex) versus daratumumab plus BorDex
Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial
The recognition from Malaysia's NPRA, a member of PIC/S, opens doors to new global business opportunities
Silica is a proven and highly effective anti-caking agent that has been used for decades
The GMP certificate will allow the manufacturing site in Hervás, Cáceres to manufacture active ingredients for the pharmaceutical industry that is based on medicinal plants
The inspection conducted by EDQM at its Visakhapatnam facility
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