Amicus Therapeutics could be just weeks away from getting EU approval for its new Pompe disease therapy Pombiliti after getting a positive opinion on the drug from the EMA's human medicines
CSL's gene therapy for haemophilia B has been recommended for approval by the EMA's human medicine committee, setting up a decision by the European Commission early next year.
Sanofi and Regeneron's Dupixent is on track to become the first targeted drug in the EU to be approved for prurigo nodularis (PN), a rare and highly debilitating skin disease.
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of Takeda GmbH’s live, attenuated dengue tetravalent vaccine, Qdenga
Sanofi and AstraZeneca are closing in on EU approval of nirsevimab, their long-acting antibody for the protection of newborns and infants from respiratory syncytial virus (RSV) infections.<
The EMA's human medicines committee (CHMP) has recommended authorisation of two COVID-19 vaccines from Moderna and Pfizer/BioNTech that include sequences coding for Omicron spike protein as
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