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First-Of Kind BMS Drugs Among Myriad New Filings In EU

US Drug Filings Have Also Been Submitted

Executive Summary

Marketing applications for 10 new drugs have been added to the latest list of products under review by the European Medicines Agency.

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New EU Filings

Ryzneuta, Evive Biotech’s treatment for chemotherapy-induced neutropenia in cancer patients, is among the latest new medicines that have been submitted for review for potential pan-EU approval.

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The European Medicines Agency says there is a possible link between the Janssen vaccine and rare cases of venous thromboembolism, and that immune thrombocytopenia should be added as an adverse reaction to the Janssen and AstraZeneca vaccines. The agency has also begun evaluating a marketing authorization application for Celltrion’s regdanvimab in COVID-19 patients.

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