-
Study reaffirms safety and tolerability profile of leading IBS medical food
BOCA RATON, Fla. - IM HealthScience on Monday announced favorable results from its Irritable Bowel Syndrome Safety Update at 6 Months (IBSSU-6), a real-world surveillance study reporting on the safety and tolerability profile of IBgard among an estimated 163,165 patients who used the product.
-
FDA rejects Amgen’s application for Parsabiv
THOUSAND OAKS, Calif. — The Food and Drug Administration has rejected Amgen’s application for the approval of its Parsabiv (etelcalcetide) , issuing a Complete Response Letter, the company said Wednesday. The drug is aimed at treating secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis.