Erytech submits MAA to European Medicines Agency for GRASPA
The MAA for GRASPA, ERYTECH’s lead product, consisting of asparaginase encapsulated in red blood cells, is based on the positive findings of the pivotal GRASPALL 2009-06 Phase 2/3
Daiichi Sankyo and Merck & Co (MSD) have voluntarily withdrawn their biologics license application (BLA) for ifinatamab deruxtecan, aimed at treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) following disease progression after platinum-based chemotherapy.
The expanded documentation and regulatory information facilitates drug product manufacturers’ risk assessment workflows and supplier qualification. The enhancements also help drug product manufacturers meet their own internal quality