Bristol-Myers Squibb: EU validates variation application.
(CercleFinance.com) - Bristol-Myers Squibb said on Tuesday that the European Medicines Agency (EMA) has validated its type II variation application, which seeks to expand the current indications for Opdivo plus Yervoy to include the treatment of advanced renal cell carcinoma.
Validation of the application confirms the submission is complete and begins the EMA's centralized review process, the US biopharmaceutical group said.
The application is based on data from a phase 3 study, which was stopped early, following the recommendation of an independent committee.
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Validation of the application confirms the submission is complete and begins the EMA's centralized review process, the US biopharmaceutical group said.
The application is based on data from a phase 3 study, which was stopped early, following the recommendation of an independent committee.
Copyright (c) 2017 CercleFinance.com. All rights reserved.