Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Maureen Kenny
Japanese company Daiichi Sankyo has its eye on first-line FLT3-ITD AML indication after rejection of relapsed/refractory plans in EU and US.
Rigel Pharmaceuticals and Jazz Pharmaceuticals are among the companies that could find out this week whether their new drug applications at the European Medicines Agency are likely to be approved for marketing across the EU. The EMA's key scientific committee, the CHMP, will also consider applications from Roche and Novartis.
Novartis is likely to hear this week whether siponomid and osilodrostat will be recommended for marketing across the EU.
Notice of the withdrawal of pan-EU marketing authorizations applications by Kiadis Pharma and Aradigm are noted in the agenda of the latest meeting of the European Medicines Agency's key scientific committee, the CHMP.
It’s decision time again at the European Medicines Agency and Roche’s Polivy is one of the new drug applications that is up for a potential marketing recommendation.
BioMarin has secured accelerated assessment at the European Medicines Agency for the planned filing of its potential new gene therapy for severe hemophilia A, Valrox. There was rejection for Amarin's Vascepa. The outcomes of more than a handful of other fast-track requests that companies have made for their planned or recent marketing authorization applications are still unknown.