The recent first global approval of emicizumab-kxwh has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Emicizumab-kxwh (Hemlibra®): First Global Approval – novel mechanism and once-weekly regimen hoped to revolutionise routine prophylaxis in patients with haemophilia A”
Month: January 2018
Letermovir (Prevymis™): First Global Approval – Distinct mechanism of action provides protection against CMV in recipients of HSCT
The recent first global approval of letermovir has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Letermovir (Prevymis™): First Global Approval – Distinct mechanism of action provides protection against CMV in recipients of HSCT”
Niraparib (Zejula™): Follow up Approval in Europe
Since the first global approval[1] of niraparib in the US, the agent has now been approved in Europe. The US approval has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[2], based on the development milestones tracked in AdisInsight.[3] Continue reading “Niraparib (Zejula™): Follow up Approval in Europe”
Durvalumab (IMFINZI®): Follow up Approval in Canada
The recent first global approval[1] of durvalumab in the US has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[2], based on the development milestones tracked in AdisInsight.[3]
In November, 2017, durvalumab (Imfinzi™), developed by AstraZeneca via Medimmune, was also approved in Canada for the treatment of advanced bladder cancer (late stage and/or metastatic disease) as monotherapy in previously treated patients (second-line or greater).[4] Continue reading “Durvalumab (IMFINZI®): Follow up Approval in Canada”