Notizie Newsletter
FDA Approval Sought for Enfortumab Vedotin for Urothelial Cancer
July 16, 2019 - A biologics license application (BLA) has been submitted to the FDA for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/PD-L1 inhibitor and who have received a platinum-containing ...Leggi tutto
FDA Approval Sought for Subcutaneous Daratumumab in Multiple Myeloma
July 12, 2019 - A supplemental biologics license application (sBLA) has been submitted to the FDA for a new subcutaneous formulation of daratumumab for the treatment of patients with multiple myeloma. The sBLA is based on findings from the phase III COLUMBA (MMY3012) study, ...Leggi tutto
PRAC recommends new measures to avoid dosing errors with methotrexate
July 12, 2019 - EMA’s safety committee (PRAC) is recommending new measures to avoid dosing errors that have led to some patients incorrectly taking methotrexate-containing medicines daily instead of weekly. The new measures include restricting who can prescribe these ...Leggi tutto
EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers
July 12, 2019 - With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in ...Leggi tutto