New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
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The loss of fast-track status for setmelanotide at the European Medicines Agency means the review of the potential treatment of two rare genetic disorders of obesity will take longer than Rhythm Pharmaceuticals had originally hoped.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add seven new products, including Nulibry, BridgeBio/Sentynl's orphan drug for treating molybdenum cofactor deficiency Type A.
Investigational products from Ultragenyx and MinervaX secured a place on the European Medicines Agency’s priority medicines scheme this month.