EMA recommends combination therapies for chronic hepatitis C virus Two new combination therapies that have the potential to cure patients with long-term hepatitis C virus infection and rule out the need for interferon are being recommended for approval across the EU.…
US FDA approves first PD-1/PD-L1 inhibitor for most common bladder cancer The US Food and Drug Administration has approved the immunotherapy atezolizumab (Tecentriq) to treat urothelial carcinoma, the most common form of bladder cancer.…
EMA recommends approval of antibiotic combination to treat multi-drug resistant bacteria A new combination antibacterial drug is being recommended for approval across the European Union (EU).…
FDA approves pimavanserin to treat hallucinations and delusions in Parkinson’s disease A drug to treat hallucinations and delusions in patients with Parkinson’s disease is being made available in the United States.…
Combination drug approved in Europe for metastatic colorectal cancer A new combination oral treatment, Lonsurf, has been granted a marketing authorisation for adults with metastatic colorectal cancer by the European Commission.…
‘One-size-fits-all’ approach will not work for drug evaluation and funding Evaluation and funding of the most promising and innovative medicines will require a separate approach to other drugs in the future, according to the chair of the government-commissioned accelerated access review.…
FDA approves venetoclax for chronic lymphocytic leukaemia The US Food and Drug Administration has approved venetoclax for the treatment of chronic lymphocytic leukaemia.…
Migalastat set for approval as first oral therapy for Fabry disease The European Medicines Agency has recommended the approval of migalastat for the treatment of the rare genetic disorder Fabry disease.…
Gene therapy for ‘bubble boy’ syndrome on track for EU approval Children with an extremely rare immune deficiency disease are set to have access to gene therapy, following a recommendation for approval by the European Medicines Agency.…
EMA recommends conditional approval of daratumumab The European Medicines Agency has recommended the multiple myeloma treatment daratumumab for conditional marketing authorisation.…
