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Keeping Track: Biosimilars, Novel Approvals, And Ebola

 
• By Michael Cipriano

The latest drug development news and highlights from our US FDA Performance Tracker include a Neulasta biosimilar approval for Sandoz, novel approvals for Celgene's Reblozyl and Giskit B.V.'s ExEm Foam, and a submission for Regeneron's Ebola candidate.

Keeping Track Feature image

Here's your US drug review and approval news for the week in brief: Sandoz Inc. finally can take its turn to celebrate, as the Novartis AG unit scored a long-awaited approval for its biosimilar of Amgen Inc.'s Neulasta (pegfilgrastim).

The Center for Drug Evaluation and Research (CDER) also cleared two more novel agents last week, granting approvals to Celgene Corp.'s Reblozyl (luspatercept–aamt) and Giskit B.V.'s ExEm Foam (air...

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