Pharma Business - May 25, 2016
Genmab’s Darzalex receives market authorization
Genmab A/S announces that the European Commission (EC) has granted a conditional marketing authorization for first-in-class CD38 antibody DARZALEX (daratumumab). The conditional approval is for the use of DARZALEX as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent […]
Drug Development Pharma - May 24, 2016
Genmab’s Darzalex approved in Europe
Genmab has announced that the European Commission (EC) has granted a conditional marketing authorization for first-in-class CD38 antibody DARZALEX (daratumumab). The conditional approval is for the use of DARZALEX as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent and […]
Drug Development Pharma - April 1, 2016
CHMP issues positive opinion recommending DARZALEX
Genmab announces that the Committee for Medicinal Products (CHMP) for Human Use of the European Medicines Agency (EMA) has issued a positive opinion recommending the grant of a conditional marketing authorization for DARZALEX (daratumumab) in the European Union. The recommendation is for the use of DARZALEX as monotherapy for the treatment of adult patients with […]
