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
Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia
Bevqolva 25 mg/mL concentrate for infusion will be available in 4 mL (100 mg) and 16 mL (400 mg) single-use vials for infusion into veins
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
Trastuzumab biosimilar is a humanized monoclonal antibody for treating metastatic breast cancer
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
The Board also decided that Auro Vaccines will explore the possibilities of offering contract manufacturing to global vaccine developers
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