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Keeping Track: US FDA Has Clinical Questions For Tricida, Gilead And BioMarin; Enspryng And Winlevi Approved

 
• By Bridget Silverman

The latest drug approval and decision news from the Pink Sheet’s US FDA Performance Tracker.

Keeping Track Feature image

The US Food and Drug Administration issued more complete response letters than approval letters for novel agents over the past fortnight. The three CRLs included CBER’s high-profile rejection of the first gene therapy for hemophilia, while the agency cleared Genentech, Inc.’s Enspryng (satralizumab-mwge) and Cassiopea S.p.A.’s Winlevi (clascoterone).

The FDA also approved a new claim and a new name for the established Novartis AG antibody ofatumumab, with...

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