The firm’s BTK inhibitor tolebrutinib has been put on clinical hold by the US FDA following liver injuries, but advanced trials should continue as normal since most patients have passed the 60-day mark.

Four orphan drugs and a new COVID-19 vaccine are among the latest products that the European Medicines Agency says should be approved.

Will BioMarin be second time lucky with its hemophilia gene therapy Roctavian in the EU? The European Medicines Agency could soon decide whether the product should be approved.

Celltrion says new data show that its Remsima SC subcutaneous infliximab biosimilar produces “statistically greater improvements in clinical outcomes” for rheumatoid arthritis patients compared to intravenous infliximab.