The EMA's human medicines committee (CHMP) has recommended authorisation of two COVID-19 vaccines from Moderna and Pfizer/BioNTech that include sequences coding for Omicron spike protein as
BioMarin Pharma has its landmark first approval for Roctavian – the first for a haemophilia gene therapy – and will now have to see if that can convert that into a viable business in Europe
Johnson & Johnson has its first worldwide regulatory approval – in the EU – for Tecvayli, one of two much-anticipated bispecific antibodies the drugmaker has developed for patients with
The European Commission has approved Oncopeptides' Pepaxti in combination with dexamethasone for multiple myeloma patients with so-called triple class refractory disease – in other words th
The European Commission has cleared AstraZeneca and Merck & Co's Lynparza as an adjuvant treatment for breast cancer, extending its lead over would-be rivals in the PARP inhibitor class
AstraZeneca and Daiichi Sankyo have claimed approval in the EU for Enhertu as a second-line therapy for HER2-positive metastatic breast cancer, moving the drug up the treatment pathway.