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Latest From Maureen Kenny
Novartis unit AveXis is one of several companies seeking extra time to address questions the European Medicines Agency has regarding their marketing applications. The company says it could get a decision on whether the product should be approved in the EU by year-end.
Companies developing new AML treatments are among those being called before the European Medicines Agency this week for questioning over marketing applications approaching the end of the review process.
It's decision time again at the European Medicines Agency and Roche's Polivy and AstraZeneca's Qternmet are among the products up for an opinion on whether they should be approved in the EU.
Tomas Salmonson and Rob Hemmings will provide consultancy services to the industry they regulated for a combined 50 years.
Will Chugai's European marketing authorization application for satralizumab be fast-tracked when the company files for approval? The European Medicines Agency's drug evaluation committee, the CHMP, will decide this week.