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Merck Announces FDA Accepts Samsung Bioepis Biologics License Application (BLA) for SB2 (Infliximab), an Investigational Biosimilar of Remicade
2016-05-24 01:50:08| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. First BLA Filed by Samsung Bioepis as Part of Its Partnership with Merck KENILWORTH, N.J. Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis Co., Ltd. for SB2 (infliximab), an investigational biosimilar candidate of Remicade. Language: English read more
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Bayer announces FDA acceptance of BAY 81-8973 BLA for treatment of hemophilia A
2015-03-04 21:03:00| Chemicals - Topix.net
Bayer HealthCare today announced that the U.S. Food and Drug Administration has accepted the company's Biologics License Application for BAY 81-8973, a recombinant Factor VIII compound. Bayer is seeking FDA approval of the investigational compound, proposed trade name Kovaltry, for the treatment of hemophilia A in children and adults.
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Amgen Submits BLA for Investigational BiTEA Immunotherapy Blinatumomab
2014-09-23 07:04:12| Biotech - Topix.net
THOUSAND OAKS, Calif., Sept. 22, 2014 /PRNewswire/ -- Amgen today announced submission of a Biologics License Application to the U.S. Food and Drug Administration seeking approval for its investigational bispecific T cell engager antibody construct, blinatumomab.
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