The U.S. Food and Drug Administration called for Eisai to pull the company’s Belviq and Belviq XR for weight loss from the market after clinical trials demonstrated an increased incidence of cancer in users.
Gelesis announced that the United States Food and Drug Administration cleared the biotechnology company’s lead product candidate Plenity (Gelesis100) as an aid in weight management in adults with a Body Mass Index (BMI) of 25–40 kg/m2, when used in conjunction with diet and exercise.
Vertex Pharmaceuticals Incorporated announced that the European Commission granted extension of the Marketing Authorization for Orkambi (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis in people with two copies of the F508del mutation, to include children ages 6 through 11.
