Biohaven Bioscience is this week scheduled to argue that its orphan drug troriluzole should be awarded EU marketing authorization during an oral explanation before the European Medicines Agency’s human medicines committee, the CHMP. The drug, if authorized, could become the first-approved treatment for the ultra-rare condition spinocerebellar ataxia.
Sponsors Of Two Orphans And An Acne Treatment To Defend Marketing Authorization Applications At EMA
Sponsors of three drugs that are in the final stages of the EU regulatory review cycle are due to make the case for marketing approval before the European Medicines Agency.
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The European Medicines Agency is this week set to issue an opinion on whether pan-EU marketing should be granted to Lilly’s Alzheimer’s disease drug donanemab.