Why do you need a European Authorised Representative?

The new Regulations for medical devices and in vitro diagnostic devices create a more robust, transparent, and sustainable regulatory framework. In this article, we will tell you all you need to know to be up to date to the new requirements implemented by the European Commission.

LK-01 Granted Orphan Drug Designation by the U.S. FDA for Acute Myeloid Leukemia

BARCELONA, Spain – Leukos Biotech, a spin-off company founded by the Barcelona based Jose Carreras Leukaemia Research Institute and supported by VCF Inveready, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for LK-01, a product based on Apomorphine, for the treatment of Acute Myeloid Leukemia. Acute Myeloid Leukaemia (AML) is […]