The FDA announced the approval of Lumizyme (alglucosidase alfa; Genzyme) for the treatment of all patients with infantile-onset Pompe disease.
The FDA announced the approval of Jardiance (empagliflozin; Boehringer Ingelheim) tablets as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
The FDA has issued a final guidance on the development, review, and approval or clearance of companion diagnostics and is intending to publish a proposed risk-based oversight framework for laboratory developed tests (LDTs).
CareFusion announced the launch of its ChloraPrep 1mL applicator, the latest addition to the ChloraPrep line.
The FDA has approved Striverdi Respimat (olodaterol; Boehringer Ingelheim) inhalation spray for the treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema with airflow obstruction.