European 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.
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Zolgensma should receive a conditional approval, says the European Medicines Agency’s drug evaluation committee, the CHMP.
Orphan drugs and COVID-19 products are among the latest filings under review by the European Medicines Agency for potential pan-EU approval.
Around 13,000 people are now expected to be eligible for treatment with the long-acting, injectable Vocabria/Rekambys combination therapy in England.