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Latest From Maureen Kenny
Tomas Salmonson and Rob Hemmings will provide consultancy services to the industry they regulated for a combined 50 years.
Will Chugai's European marketing authorization application for satralizumab be fast-tracked when the company files for approval? The European Medicines Agency's drug evaluation committee, the CHMP, will decide this week.
It’s hard enough in the first place for companies to persuade the European Medicines Agency that their planned marketing authorization application should be fast-tracked. Many are also finding that after accelerated assessment is granted, it is taken away during the actual review.
PTC Therapeutics and Novartis are working on their next steps after the European Medicines Agency recommended against approving their requests to expand the indication of their respective products in the EU.