New EU plan to boost orphan medical devices
The European Medicines Agency (EMA) has launched a pilot programme to support the development and assessment of orphan medical devices in the European Union (EU). The initiative offers… read more.
The European Medicines Agency (EMA) has launched a pilot programme to support the development and assessment of orphan medical devices in the European Union (EU). The initiative offers… read more.
The FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the following treatment indications, which are… read more.