High-Stake Meetings With EMA In Store For Sponsors Of EU Filings
The sponsors of six drugs that are nearing the end of the regulatory review cycle in the EU could this week be asked to explain why the European Medicines Agency should recommend approving their products.
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Its crunch time for sponsors of more than a dozen products as the EMA meets to adopt opinions on several marketing authorization applications.
The European Medicines Agency has cleared the decks for the pan-EU approval of nearly a dozen new drugs. Tecvayli is headed for a conditional approval, while Nulibry is slated to get marketing authorization under exceptional circumstances.