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.…
FDA approves first treatment for stem cell transplant patients who develop rare liver condition The US Food and Drug Administration has approved a new treatment for hepatic veno-occlusive disease, a rare and life threatening liver condition that can develop in cancer patients who undergo hematopoietic stem cell transplantation.…
GSK softens approach to patents to widen access to its medicines GlaxoSmithKline has announced a series of measures designed to widen access to its medicines in the world’s poorest countries.…
Teva’s injectable asthma biologic approved by FDA The US Food and Drug Administration has approved Teva Pharmaceutical Industries’ humanised monoclonal antibody reslizumab (Cinqair) as a treatment for severe asthma.…
FDA approves anthrax treatment The US medicines safety watchdog has approved obiltoxaximab (Anthim) for the treatment of inhalational anthrax in combination with other therapies and when other treatments are either unavailable or inappropriate.…
