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.

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

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.

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.