Last-Minute Pushback On Janssen’s EU Spravato Approval
Third Parties Intervene After CHMP Supports Drug’s EU-Wide Approval
What is in store for esketamine after third parties submit written interventions to the European Medicines Agency?
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Spravato has been approved for treatment-resistant depression in the EU notwithstanding last-minute objections by third parties.
Products from Novartis, Celgene and Merck could get an EU approval recommendation at this week's CHMP meeting.
Seven new products, including the world’s first ever Ebola vaccine, are on track to receive EU-wide approval. Meanwhile, two drugs have failed to make the grade.