Drug Approval | April 28, 2025
CuraTeQ Biologics receives positive opinion for biosimilar Dazublys from EMA
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein
This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets
YESINTEK, is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease
Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia
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
Successfully transformed the organization from a two-country operation focused on development and manufacturing to a fully integrated company with a strong commercial engine bringing us closer to patients in over 120 countries
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
MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA
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