European CHMP Opinions and MAA Updates
Executive Summary
This is a monthly update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
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Molteni Farmaceutici/Titan’s Sixmo, the first six-month buprenorphine implant just approved for EU marketing, could be a valued option for a sizeable number of patients.
ViiV’s Potential HIV Blockbuster Among Latest Drugs To Win EMA Nod
A total of 13 new drugs have been recommended for pan-EU approval, while one has failed to meet the European Medicines Agency’s standards.
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.