Bayer Seeks Speedy EMA Review For Diabetic Kidney Disease Drug Finerenone
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.
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Plenty Of Action On EU Accelerated Assessment Front
A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.
EU Accelerated Assessment Tracker
Sanofi failed in its attempt to have its EU marketing authorization application for avalglucosidase alfa fast-tracked through the centralized review process at the European Medicines Agency. This and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.
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.