The US Food and Drug Administration has approved an expansion of the approved use of Gleevec (imatinib) to increase the time during which the drug is effective in patients with CD117-positive gastrointestinal stromal tumours (GIST). The developer of the drug is Novartis.
The US Food and Drug Administration has approved a new personalised medicine, Kalydeco (ivacaftor), for a rare form of cystic fibrosis, the first treatment to target a mutation in the cystic fibrosis transmembrane regulator (CFTR) gene.
The US Food and Drug Administration has approved a skin cancer drug from Roche, Erivedge (vismodegib), its first ever approval of a treatment for metastatic basal cell carcinoma. Erivedge works by inhibiting the Hedgehog pathway.
In an apparently unprecedented situation, a committee of the European Union member states which advises the European Commission on the granting or refusal of marketing authorisations, has reached an impasse over the gene therapy, Glybera.
After two earlier rejections, a once-weekly treatment for type 2 diabetes, Bydureon (exenatide extended-release), has received clearance from the US Food and Drug Administration. The sponsors are Amylin Pharmaceuticals Inc and Alkermes Plc.
The US Food and Drug Administration has approved Inlyta (axitinib) for the treatment of advanced renal cell carcinoma, the seventh drug to be authorised for this indication since 2005, the agency said. The developer is Pfizer Inc.
Sanofi SA has received FDA approval of its plant in Framingham, Massachusetts with the result that it can start restoring supplies of its treatment for Fabry disease. The FDA approval follows earlier approval by the European Medicines Agency.
The US Food and Drug Administration has approved the first diagnostic that will enable healthcare professionals to determine whether a patient taking the multiple sclerosis drug, Tysabri (natalizumab), faces a risk of the brain infection, PML.
Novartis’s new treatment for Cushing’s disease, a rare hormonal disorder, has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
The European Medicines Agency has announced the start of a safety review of the Novartis treatment for multiple sclerosis, Gilenya (fingolimod), less than a year after the drug was authorised for marketing in the European Union.