AstraZeneca and Daiichi Sankyo have achieved a significant regulatory milestone after the European Commission approved Enhertu (trastuzumab deruxtecan) for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have no satisfactory treatment options.

US Food and Drug Administration (US FDA) has accepted two Abbreviated New Drug Applications (ANDAs) of Sandoz for review, marking an important milestone in the company's efforts to introduce generic versions of tirzepatide in the United States.

The applications cover generic tirzepatide autoinjectors developed entirely through Sandoz's in-house research and development program. If approved, the products could become among the first generic alternatives to Mounjaro® and Zepbound®, expanding access to one of the fastest-growing classes of medicines used for diabetes and obesity.