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Regulation & Policy
Gleevec given expanded indication for gastrointestinal cancer
Wednesday 1 February 2012
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.
Location
United States
FDA approves personalised therapy for cystic fibrosis
Tuesday 31 January 2012
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.
Location
United States
FDA approves Erivedge for skin cancer
Tuesday 31 January 2012
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.
Location
United States
Glybera marketing authorisation application in limbo
Monday 30 January 2012
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.
Location
Netherlands
FDA approves once-weekly drug for diabetes
Monday 30 January 2012
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.
Location
United States
FDA approves Inlyta for kidney cancer
Monday 30 January 2012
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.
Location
United States
FDA approves Sanofi plant
Tuesday 24 January 2012
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.
Location
France
FDA approves first test for risk of PML
Monday 23 January 2012
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.
Location
United States
New drug for Cushing’s disease gets positive opinion
Friday 20 January 2012
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.
Location
United Kingdom
EMA announces safety review of Gilenya
Friday 20 January 2012
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.
Location
United Kingdom
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Recent Appointments
Rajesh Chopra joins e-Therapeutics’s Board of Directors
Tuesday February 7 2012
Carolyn Compton named CEO of Critical Path Institute
Friday February 3 2012
John Perkins appointed UK chief scientific advisor
Monday January 23 2012
Briggs Morrison to lead global medicines development at AstraZeneca
Wednesday January 11 2012
Russell Greig appointed chair of AM-Pharma supervisory board
Wednesday January 4 2012