EMA fast tracks approval of thyroid cancer drugThe European Medicines Agency is recommending that Lenvima (lenvatinib) be available across Europe for the treatment of some patients with thyroid cancer.…
Analysts predict surge in ‘blockbuster drugs’ entering the market in 2015Over the next twelve months there will be 11 “blockbuster” drugs entering the market, according to business intelligence company Thomson Reuters.…
FDA approves cholic acid for rare bile acid synthesis disordersCholic acid, a drug used to treat bile acid synthesis disorders and peroxisomal disorders, has been approved by the US Food and Drug Administration.…
US FDA approves drug that prolongs survival in rare paediatric cancer The US Food and Drug Administration has approved dinutuximab as part of first-line therapy for a rare childhood cancer, neuroblastoma. …
FDA grants priority approval for new antifungalIsavuconazonium sulfate, an antifungal developed by Astellas, has been given priority approval by the US Food and Drug Administration to treat serious infections.…
Skin cancer drug fast tracked under early access to medicines schemeA drug for advanced skin cancer, pembrolizumab, has become the first medicine to be fast tracked to patients under the UK’s early access to medicines scheme.…
US FDA approves antibiotic combination with new beta-lactamase inhibitor The US Food and Drug Administration has approved a new intravenous antibacterial product, Avycaz, which contains ceftazidime and a new beta-lactamase inhibitor, avibactam.…
FDA fast tracks approval of panobinostat for multiple myeloma The US Food and Drug Administration has fast-tracked the approval of the first histone deacetylase inhibitor to treat patients with multiple myeloma.…
Licensing deal will allow paediatric HIV drug to be used more widelyChildren with HIV in developing countries will now have access to generic paediatric formulations of raltegravir following a licence agreement with Merck.…
Breast cancer drug palbociclib gets expedited approval in United States The US Food and Drug Administration has approved palbociclib (Ibrance; Pfizer) for advanced (metastatic) breast cancer under its accelerated approval programme.…