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.

This is a regularly updated searchable list of products that have been filed with the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) under the EU's centralized authorization procedure. The information is based on the EMA's monthly updated list of medicines under review at the agency, CHMP monthly meeting agendas, company press releases, and original research by the Pink Sheet. 

The EMA's latest monthly filings list, which comprised data extracted on 6 October, included marketing authorization applications (MAAs) for 10...

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<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>

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As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.

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<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>

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Diversity Action Plans: What To Submit And When

 
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.