EU Fast-Track Review In Store For Takeda’s Dengue Vaccine
Accelerated Assessment Also For New Therapies From Regeneron And Bluebird Bio
Takeda will soon seek EU approval of its dengue vaccine candidate. The marketing application will be fast-tracked, as will the applications for Regeneron's evinacumab and bluebird bio's eli-cel Lenti-D gene therapy.
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Voraxaze, vosoritide and TransCon hGH are among the latest products that have been submitted to the European Medicines Agency for review for potential pan-EU marketing approval.
Two products that were under fast-track review at the European Medicines Agency have reverted to standard review timelines – Eiger's lonafarnib and GSK's dostarlimab. The Pink Sheet tracker logs these and other developments relating to the agency's accelerated assessment mechanism.
Keeping Track: Veklury NDA Arrives At US FDA; Olinvyk Sees Approval; MAb Filings By Regneron, Y-mAbs
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.