The Danish pharmaceutical giant Novo Nordisk recently announced the application for a BLA and a marketing authorization application (MAA) for the long-acting hemophilia drug N8-GP to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively. 89 more words
Tags » Hemophilia A
A family medicine physician cares for a family in which both the grandfather and young grandson have hemophilia A. Recently, the grandfather came for a check-up on his arthritis and asked the physician, “Is there anything new for hemophilia that can help my grandson avoid what I’ve been through over the years? 461 more words
Hemlibra was approved by the FDA as the first new drug to treat hemophilia A in the body in the past 20 years.
Sandra Horning, Roche’s chief medical officer and head of global product development, said: ” the approval of Hemlibra is of great significance for hemophilia A patients who have factor VIII inhibitors in the body. 54 more words
FDA approves new treatment Hemlibra (emicizumab-kxwh) to prevent bleeding in certain patients with hemophilia A
The U.S. Food and Drug Administration today approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors. 644 more words
BioMarin announced the results from their ongoing Phase 1/2 gene therapy studies evaluating BMN 270 for patients with hemophilia A. Based on encouraging data, Phase 3 studies are being planned to start later this year. 433 more words