Health Canada approved the first generic version of Novo Nordisk’s Ozempic (semaglutide) based on Dr. Reddy’s Laboratories’ submission. The regulator said the generic meets safety, efficacy, and quality standards and is pharmaceutically equivalent to the brand for once-weekly treatment of adults with type 2 diabetes. In FDA device development, PreludeDx’s early-stage breast cancer test, which provides prognostic risk assessment and predicts radiation therapy benefit, received FDA Breakthrough Device designation. The company is positioning the test to support earlier, biology-informed decisions in invasive early-stage breast cancer. Separately, Laguna Diagnostics’ mRNA gene biomarker test for differentiating schizophrenia and bipolar I disorder received an FDA Breakthrough Device designation. The company cited high performance in a pivotal study and said the test is intended to be used alongside clinical assessment. The approvals and designations underscore regulators’ continuing focus on reducing uncertainty in diagnosis and treatment selection while enabling faster pathways for clinically meaningful tools.