Enhertu (fam-trastuzumab deruxtecan-nxki) received FDA regular approval for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy.
The Supreme Court last week upended one of the underpinnings of administrative law by weakening the authority of federal health agencies to rely on technical expertise as they regulate medical products, issue coverage decisions, and respond to public health crises.
