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Latest From Maureen Kenny
KTE-X19, Kite’s potential new CAR-T therapy, will in the end be fast-tracked at the European Medicines Agency. Lilly failed to secure the speedy review it was seeking for selpercatinib
Priority review is likely in the US for Kite’s second CAR-T therapy offering but it seems the company will have to make do with standard review in the EU.
Hot on the heels of winning EU fast-track review status for belantamab mafodotin, GlaxoSmithKline has asked the European Medicines Agency to grant accelerated assessment to another of its planned marketing applications.
The head of the European Medicines Agency is nearing the end of his tenure. We consider Guido Rasi’s achievements over the past 10 years as well as the controversies that have arisen under his leadership – and report that sailing is likely to figure in his plans for life after the agency.
The EU product information for Ibrance, Verzenios and Kisqali is being updated to include interstitial lung disease and pneumonitis. The change has already been implemented in the US.