Shots: The approval was based on P-III trial from the ASCERTAIN study supporting P-I and P-II clinical studies which evaluated the safety and efficacy including decitabine exposure equivalence in oral […]readmore
Tags : Received
Shots: The approval is based on P-III study which involves assessing of leuprolide acetate (LA,45 mg) in 64 children with central (gonadotropin-dependent) precocious puberty evaluating its safety and pharmacokinetics The […]readmore
The partner received Registration Certificate for its Acellbia (biosimilar, rituximab) and Herticad (biosimilars, trastuzumab) in Bosnia and Herzegovina, countries on the Balkan Peninsula in Southeastern EU. The Agency for Medicinal […]readmore
Shots: The approval is based on the study assessing of Absorica vs another isotretinoin 925 patients aged 12 years and older in patients with severe recalcitrant nodular acne Study results: […]readmore
Shots: The approval is based on two P-III study results assessing Talicia vs active comparator arm and resulted in eradication of H. pylori infection (84% vs 58%), response rate @13 […]readmore