Brian Park, PharmD

All articles by Brian Park, PharmD

The FDA has granted Breakthrough Therapy designation to apabetalone (Resverlogix Corp) in combination with standard of care therapy, including high-intensity statins, for the secondary prevention of major adverse cardiac events (MACE) in patients with type 2 diabetes mellitus and recent acute coronary syndrome.

The Food and Drug Administration (FDA) has granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki; AstraZeneca and Daiichi Sankyo) for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received 2 or more prior anti-HER2-based regimens in the metastatic setting.  The approval was based on results from the phase 2, open-label, single-group,…