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LatestLicenses And Certifications 18 July 2026

Insomnia Drug Application

The European Medicines Agency has accepted Eisai's application for the insomnia drug lemborexant, which could potentially bring relief to millions of people suffering from insomnia, the application is currently under review and a decision is expected in the coming months, the US Food and Drug Administration has also approved a supplemental Biologics License Application for Eisai's Alzheimer's drug Leqembi

The European Medicines Agency has accepted *Eisai's* application for the insomnia drug *lemborexant*. Key points of the application include:
- The drug is intended to treat insomnia in adults
- The application is currently under review
- A decision is expected in the coming months
The *US Food and Drug Administration* has also approved a supplemental Biologics License Application for *Eisai's* *Alzheimer's* drug *Leqembi*

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