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Latest From Advicenne

Advicenne Hastens EU Approval For Sibnayal By Withdrawing Orphan Designation

 Advicenne withdrew its orphan drug designation application for Sibnayal over concerns that a key study was not designed to compare the product with the standard of care.

Europe Rare Diseases

Advicenne Ramps Up EU Marketing Plans For Rare Kidney Disease Drug

Sibnayal, Advicenne’s innovative treatment for distal renal tubular acidosis, is set to be approved for use in the EU shortly.

Europe Approvals

Early EU Approval Wins In Line For Daiichi/AZ & Lilly

Advanced breast cancer treatment Enhertu and non-small cell lung cancer and thyroid cancer therapy Retsevmo are set to win conditional marketing authorizations in the EU shortly. The two drugs are among a number of new products that the European Medicines Agency has just recommended for approval.

Europe Approvals

Raft Of New Drugs To Learn EU Marketing Fate

ViiV Healthcare’s “last resort” HIV drug, fostemsavir, is one of 16 new medicines that are up for an opinion by the European Medicines Agency on whether they should be authorized for use across the EU.

Europe Approvals
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