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Bosulif is an oral, once-daily, tyrosine kinase inhibitor, which inhibits the Bcr-Abl kinase that promotes CML. The BFORE study met its primary endpoint of major molecular response (MMR)

The companies believe this submission is the first bevacizumab biosimilar application submitted to the EMA. Amgen Research and Development executive vice president Sean E. Harper, M.D. said: "The

VONVENDI is an on-demand recombinant treatment for adults living with VWD and replaces von Willebrand factor (VWF), one of several types of proteins in the blood that are

Pfizer announced new data from a randomized Phase 2 study of glasdegib (PF-04449913), an oral, smoothened (SMO) inhibitor, showing the addition of glasdegib to low-dose cytarabine (LDAC) significantly

The company submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg). The company submitted its MAA in the US several weeks

Jardiance can now be used to reduce the risk of cardiovascular death in adult patients with type 2 diabetes (T2D) mellitus and cardiovascular disease (CVD). The agency’s decision

The EC’s approval follows a positive opinion in October from the European Medicine Agency’s (EMA) Committee for Orphan Medicinal Products (COMP). Earlier this year, Agilis received Orphan Drug

Pimavanserin is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors that may play a role in depression. Massachusetts General Hospital (MGH) Department of Psychiatry executive vice

Fast Track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions and address an unmet medical need. The designation enables