Obesity Drug Imcivree Among Eight New Products To Win EMA Nod
The European Medicines Agency today revealed the names of the latest new products it believes should be approved for use across the EU.
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Idorsia’s Insomnia Drug Daridorexant Among 14 Hopefuls For EU Verdict
The European Medicines Agency will likely decide this week whether to recommend for pan-EU approval new treatments for insomnia, uveal melanoma, migraine and advanced prostate cancer.
EU Accelerated Assessment Tracker
Novartis is one of the latest companies to fail in its attempt to have a marketing authorization application fast-tracked at the European Medicines Agency. There was better news for BioMarin.
EU CHMP Opinions and MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.