Second Time Lucky For Dynavax’s Hep B Vaccine In 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.
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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.
Paion’s novel sedation drug, remimazolam, was approved in the US, China, and Japan this year and now the European Medicines Agency is set to decide whether it should be authorized for use across the EU.