- Baxter International (BAX -0.1%) submits a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare seeking approval of BAX 855, an investigational extended half-life recombinant factor VIII treatment for hemophilia A patients at least 12 years old.
- BAX 855 is based on ADVATE, the company's recombinant factor VIII launched in 2003, that contains no blood-based additives. This eliminates the potential risk of transmitting pathogens.
- The firm filed an BLA in the U.S. in late 2014.
- Previously: Baxter submits BLA for extended half-life hemophilia treatment (Dec. 1, 2014)
Baxter submits marketing app in Japan for long acting hemophilia A treatment
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