Medicines licensing

EMA fast tracks approval of elotuzumab for multiple myeloma

The European Medicines Agency is recommending that elotuzumab (Empliciti) is fast tracked for use as a combination therapy for the treatment of patients with the rare and incurable blood cancer multiple myeloma.…

FDA approves URAT1 inhibitor lesinurad to treat gout

A new treatment for gout that blocks the reabsorption of uric acid in the kidneys has been approved by the US Food and Drug Administration.…

FDA approves selexipag for pulmonary arterial hypertension

The US drugs safety regulator has approved selexipag to treat adults with pulmonary arterial hypertension, a chronic, progressive lung disease that causes high pressure in the arteries that connect the heart to the lungs.…

Alectinib approved by FDA for ALK-positive lung cancer

Alectinib, a new drug for anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer, has been approved by the US Food and Drug Administration.…

FDA approves uridine triacetate as chemotherapy overdose rescue

A new rescue treatment for patients accidentally given an overdose of chemotherapy has been approved by the US Food and Drug Administration.…

Smoking cessation services will not be bound by e-cigarette advertising restrictions

Pharmacists running smoking cessation services in England, Wales and Northern Ireland will still be able to promote the option of e-cigarettes under new European advertising rules coming into force in 2016.…

World’s first vaccine against the Dengue virus approved in Mexico

The first vaccine in the world to prevent the dengue virus has been approved for use in Mexico, the country’s drugs regulator has announced.…

FDA approves treatment for inherited bleeding disorder

Recombinant von Willebrand factor, a treatment for an inherited bleeding disorder, has been approved by the US Food and Drug Administration.…

New heart failure drug extends survival by up to two years

A re-analysis of trial data reveals that the highly effective new drug sacubitril-valsartan could extend life by two years compared with enalapril for cardiovascular patients.…

FDA approves new multiple myeloma drug elotuzumab

A new immune-stimulating treatment for multiple myeloma has been approved by the US Food and Drug Administration.…