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Tag: European Medicines Agency

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MHRA approves first drug via the new IRP in 30 days

XGEVA is the first product to be authorised by the regulator through the new International Recognition Procedure (IRP). The latest formulation of XGEVA (denosumab)...

EMA recommends approving GSK’s oral therapy for rare blood cancer

A decision on EU marketing authorisation for oral therapy is expected by early 2024. The Committee for Medicinal Products for Human Use (CHMP) of...

Eisai files for approval of Alzheimer’s drug in Europe

Japanese drugmaker Eisai said on Tuesday (January 10) it had submitted a marketing application to the European health regulator for review of its Alzheimer's...

European Medicines Agency backs gene therapy to treat rare bleeding disorder

The European Union's health regulator on Friday said it had recommended granting a conditional marketing authorization for a gene therapy by Australian drugmaker CSL...

‘Disappointing’ COVID-19 booster uptake worries Europe’s head of vaccines strategy

Recent uptake of COVID-19 vaccine booster doses in Europe has been "rather disappointing," an official said on Thursday (November 24), amid concerns that protection...