First treatment for blind people with rare sleep disorder gets the go-ahead in Europe A drug to treat a rare sleep disorder almost exclusively affecting blind people has been recommended for authorisation by the European Medicines Agency.…
FDA fast tracks ivabradine’s heart failure licence, years after EuropeThe US Food and Drug Administration has granted a licence for the heart failure medication ivabradine, ten years after the drug was first approved in Europe.…
Indian government stands up to EMA over licence suspensionsThe Indian government has come to the defence of GVK Biosciences, the company at the centre of allegations of flawed data used to support the licensing of generic drugs.…
Gates Foundation aims to cut drug registration times by 50% in sub-Saharan Africa by 2018 Speeding up the time it takes to register drugs, vaccines and diagnostics in low and middle income countries is a key strategy for the Bill and Melinda Gates Foundation.…
Medicines regulators set out priorities for next five yearsMedicines regulators across Europe have set out their priorities for the next five years in a proposed strategy now out for consultation.…
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.…
