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.…
FDA approves coagulation factor-albumin fusion protein to treat haemophilia B Idelvion, a coagulation factor-albumin fusion protein product for use in children and adults with haemophilia B, has been approved by the US Food and Drug Administration.…
EMA launches Priority Medicines Scheme A new initiative to support drug companies developing therapies with the potential to address unmet medical needs and bring them to market more quickly has been launched by the European Medicines Agency.…
New research suggests female libido drug offers ‘marginal’ benefits Flibanserin (Addyi), dubbed the “female Viagra”, offers “marginal” benefits to women who suffer from hypoactive sexual desire disorder, according to new research.…
