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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The sponsors of 11 new treatments should learn this week whether the European Medicines Agency will recommend EU marketing approval for their products.
The Phase III FIDELIO trial of finerenone has been a success but analysts want to see some actual data before declaring it an unqualified one.
Antimicrobial resistance, the lack of new antibiotics, and preserving the effectiveness of existing ones are high on the agenda for the soon-to-be new head of the European Medicines Agency, Emer Cooke.