FDA2017 – Drug Approvals International

FDA approves Admelog, the first short-acting “follow-on” insulin product to treat diabetes

FDA approves Admelog, the first short-acting “follow-on” insulin product to treat diabetes The U.S. Food and Drug Administration today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type …

FDA approves first biosimilar Herceptin (trastuzumab) for the treatment of certain breast and stomach cancers

FDA approves first biosimilar for the treatment of certain breast and stomach cancers Ogivri, a biosimilar to the cancer drug Herceptin, is approved for HER2+ breast cancer and metastatic stomach cancers The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or …