Global Pharma Guidance Tracker – June 2021
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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EU reviewers have recommended marketing approval for two new medicines, but have turned down another product.
The European Medicines Agency is meeting this week to consider applications to broaden the use of approved drugs to include new indications in the EU.
The marketing application for obeticholic acid, Intercept’s potential new treatment for advanced fibrosis due to nonalcoholic steatohepatitis (NASH), was rejected in the US and now the company says it needs extra time to respond to questions about its EU filing.