EU CHMP Opinions And MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
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The European Medicines Agency has recommended the conditional approval of Mirati’s lung cancer drug Krazati following a re-examination of its initial negative opinion.
Three orphan drugs were among the eight products recommended for pan-EU marketing approval by the European Medicines Agency this week, while Novartis withdrew its filing for Vijoice.
Santhera Pharmaceuticals’ Agamree is on track to receive pan-EU approval to treat Duchenne muscular dystrophy before the year-end. The company’s CEO and CMO tell the Pink Sheet about its regulatory experience and future market access strategy.