Orphan AML Products Face CHMP Questioning
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.
You may also be interested in...
Will regulators in the EU follow their US counterparts in requiring more efficacy data for Daiichi Sankyo’s acute myeloid leukemia drug quizartinib, which is already approved in Japan?
Seven new drugs have this week moved closer to gaining EU approval following positive recommendations from the European Medicines Agency, but Emmaus’ glutamine product has fared less well and the company is considering another route for getting the drug to sickle cell disease patients in Europe
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.