First-Of Kind BMS Drugs Among Myriad New Filings In EU
US Drug Filings Have Also Been Submitted
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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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.
Coronavirus Notebook: Sanofi Under Pressure To Hand mRNA Vaccine To Africa, EMA OKs Booster Dose For Comirnaty
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.
In contrast with the five COVID-19 vaccines that are approved in the EU under conditional marketing authorizations, the European Medicines Agency has recommended that Valneva’s vaccine receive a standard approval.