Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population
Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A
Final decision from the European Commission is anticipated within the coming months
Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells
For people with relapsed or refractory diffuse large B-cell lymphoma
The first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma
Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years
Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype
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