Moment Of Truth For Daiichi/AstraZeneca’s Enhertu In EU
The EU marketing application for the HER2-targeted antibody drug conjugate has been fast-tracked and is now up for an opinion from the European Medicines Agency.
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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.
The European Medicines Agency is set to decide whether Dynavax’s “fewer dose” Heplisav-B vaccine should be authorized for use across the EU – years after the company experienced a setback with its first attempt to get the vaccine approved.