Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia
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
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually
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
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
MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA
Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization
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