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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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.
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.
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.