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European Commission approves Durveqtix (fidanacogene elaparvovec), a one-time gene therapy for adults with hemophilia B – Pfizer

Written by | 1 Aug 2024

Pfizer Inc. announced that the European Commission (EC) has granted conditional marketing authorization for Durveqtix (fidanacogene elaparvovec), a gene therapy for the treatment of severe and moderately severe… read more.

CHMP positive recommendation for Durveqtix (fidanacogene elaparvovec) to treat haemophilia B – Pfizer

Written by | 9 Jun 2024

The Committee for Medicinal Products for Human Use (CHMP) has recommended granting conditional marketing authorization in the EU to Pfizer’s hemophilia B gene therapy Durveqtix (fidanacogene elaparvovec). Durveqtix,… read more.

Health Canada approves Hemgenix (etranacogene dezaparvovec) for treating adults with hemophilia B who rely on routine prophylactic therapies to prevent or reduce bleeding episodes – CSL Behring

Written by | 20 Nov 2023

Health Canada has approved the gene therapy Hemgenix (etranacogene dezaparvovec) for treating adults with hemophilia B who rely on routine prophylactic therapies to prevent or reduce bleeding episodes…. read more.

CHMP extends the indication of Refixia to prophylaxis of bleeding in patients 12 years and above with haemophilia B – Novo Nordisk

Written by | 30 Jun 2023

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Refixia…. read more.

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