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Recent And Upcoming FDA Advisory Committees

Executive Summary

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

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New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, including Blueprint Medicines' Ayvakyt for treating unresectable or metastatic gastrointestinal stromal tumors. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).

EU Biosimilar Filings, Opinions And Approvals

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.

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