The Committee for Medicinal Products for Human Use (CHMP) has recommended granting a conditional marketing authorization for Autolus GmbH’s Aucatzyl (obecabtagene autoleucel) in the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-cell ALL). B-cell ALL is a type of cancer affecting the white blood cells. Autolus GmbH’s medicine was supported through the […]
Category: EMA Approval
CDSCO Approves Fabrazyme Label Update for Sanofi EMA Submission
The Central Drugs Standard Control Organization (CDSCO) panel has granted approval for an update to the Fabrazyme label, directing Sanofi to submit the nod from the European Medicines Agency (EMA). This decision marks a significant step in ensuring compliance with regulatory requirements and aligning the product information with current standards. Fabrazyme, a medication used in […]
