Clinical Research Solutions
FDA has accepted for review the first NDA for a “digital” medicine product. The product, which is produced by Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health, is the first-ever medication...
Clinical Research Solutions
On February 25, 2015, FDA approved Toujeo, a once-daily, long-acting recombinant insulin. A year earlier an inhaled formulation of insulin, Afrezza, was approved. These recent additions to the...
Clinical Research Solutions
Following extensive marketing of Lovenox® (enoxaparin sodium), a low-molecular weight heparin, a number of biosimilar versions of enoxaparin and one ANDA-approved formulation (enoxaparin sodium,...