beeldscherm schreef op 5 januari 2018 09:55:
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Seattle Genetics files U.S. marketing application for expanded use of Adcetris
Nov. 2, 2017 9:41 AM ET|About: Seattle Genetics, Inc. (SGEN)|By: Douglas W. House, SA News Editor
Seattle Genetics (SGEN -0.1%) submits a supplemental Biologics License Application (sBLA) to the FDA seeking approval to use ADCETRIS (brentuximab vedotin), in combination with chemotherapy, for the first-line treatment of patients with advanced classical Hodgkin lymphoma (HL), a Breakthrough Therapy indication.
ADCETRIS is currently approved in the U.S. for HL after the failure of hematopoietic stem cell transplantation (HSCT) or after the failure of at least two prior chemo regimens, HL at high risk of relapse post-HSCT and systemic anaplastic large cell lymphoma after the failure of at least one prior line of chemo.
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FDA Accepts Supplemental Biologics License Application and Grants Priority Review for ADCETRIS® (Brentuximab Vedotin) in Frontline Advanced Hodgkin Lymphoma
Business Wire Business WireJanuary 2, 2018
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Dus Pharming zou de goedkeuring voor Ruconest Profylactisch ook elk moment op de deurmat kunnen vinden m.i. .....