The US Food and Drug Administration has extended the approved indication for the blood-thinning drug Brilinta (ticagrelor) to include the long-term use in patients with a history of heart failure. The approval was announced on 3 September.
Repatha (evolocumab), a new drug for lowering cholesterol in patients with cardiovascular disease or familial hypercholesterolemia, has been approved by the Food and Drug Administration. Developed by Amgen, the drug received a positive opinion from the European Medicines Agency in May.
A new drug intended to treat low sexual desire in women has been approved by the US Food and Drug Administration. Addyi (flibanserin) is the first pharmaceutical for this condition, which is known as hypoactive sexual desire disorder (HSDD).
A new vaccine designed to protect young children in sub-Saharan Africa from infection from thePlasmodium falciparum parasite has been given a positive opinion by the European Medicines Agency even as its effectiveness was described as modest.
Proposed legislation that would increase funding for US biomedical research and promote personalised medicine passed the House of Representatives on 10 July and was sent to the Senate for debate.
Following a request from Denmark, the European Medicines Agency has begun a review of the safety of the human papillomavirus vaccines Gardasil and Cervarix to find out whether or not reports of two rare adverse events are linked to the vaccines.
Vertex Pharmaceuticals Inc has won approval in the US for a second drug to treat cystic fibrosis, this time for a treatment targeting the F508del mutation, the most common cause of the disease. Called Orkambi (lumacaftor/ivacaftor), the drug is indicated for patients who have two copies of the mutation.
Novo Nordisk A/S has become the latest producer of a diabetes medicine to stop supplying the German market following a disagreement over pricing. Novo will cease supplying Tresiba (insulin degludec) in Germany after 30 September 2015.
The European Medicines Agency has recommended the approval of the first histone deacetylase (HDAC) inhibitor for the treatment of multiple myeloma, a rare cancer of the white blood cells. The drug, Farydak (panobinostat), was developed by Novartis.
A new implantable deep brain stimulation device has been approved by the Food and Drug Administration for patients with symptoms of both Parkinson’s disease and essential tremor, two discrete disorders for which there are no medical cures.