Keeping Track: Four Novel Agents Clear US FDA, Including Evrysdi, Blenrep
The latest US FDA approvals and actions from the Pink Sheet’s US FDA Performance Tracker.
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GSK’s Blenrep: 15 Days From Confirmatory Trial Failure To Withdrawal Announcement
The first BCMA-targeting agent to gain approval in myeloma never became the blockbuster for which GSK had hoped, but Blenrep appears to have set a new standard for speed of voluntary withdrawal of an accelerated approval drug after a confirmatory trial failure.
Bayer’s Lampit Has Unique Status: US FDA’s Most ‘Critical’ Approval In 2020
Among the 53 new molecular entities cleared by FDA in 2020, Bayer’s Chagas disease therapy Lampit has a unique distinction: the approval required an in-person inspection that FDA actually conducted amid the COVID-related shutdown of routine pre-approval site visits.
EU: BTG Tries Again With Voraxaze After 15 Years
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.