GSK: Please, EMA, Can We Have Some More?
Company Is Seeking Another Speedy Review
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.
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New drugs from Eli Lilly, Pfizer, Janssen, GSK, Arvelle, BioCryst, Diurnal and Myovant are also among the latest products the European Medicines Agency is evaluating for potential pan-EU approval.
EU marketing applications from Vertex and Roche have reverted to standard review timelines at the European Medicines Agency. The outcomes of three fast-track requests that companies have made for their planned filings are still unknown.
By combining its expertise in respiratory and vaccines, the UK drugs giant could have a potential blockbuster for chronic obstructive pulmonary disease, which is expected to become the third leading cause of death worldwide by the end of the decade.