EMA: Moment Of Truth For Two Curative Therapies & A Possible Cholesterol-Lowering Blockbuster
The sponsors of 11 new treatments should learn this week whether the European Medicines Agency will recommend EU marketing approval for their products.
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BioMarin plans to resubmit its marketing application for Roctavian to the European Medicines Agency.
The developers of three drugs are hoping the European Medicines Agency will decide that their products merit fast-tracking when they are submitted for review for potential pan-EU approval.
Novartis has pooled cholesterol control and safety data, but will have to wait longer for cardiovascular outcomes readout.