Keeping Track: US FDA Greenlights Two More Novel Drugs, But Smacks Down Golodirsen
The latest drug development news and highlights from our US FDA Performance Tracker.
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Agency offers Vanda chance to request a hearing over its plan to refuse to approve its supplemental new drug application. Such a hearing seems unlikely given FDA’s rejection of past requests and Vanda’s track record with the agency.
Keeping Track: US FDA Has Clinical Questions For Tricida, Gilead And BioMarin; Enspryng And Winlevi Approved
The latest drug approval and decision news from the Pink Sheet’s US FDA Performance Tracker.
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.