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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Vanda May Go Another Round With US FDA Over Hetlioz Jet Lag Indication
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.
Keeping Track: J&J Submits Ponesimod NDA For MS; US FDA Clears Epclusa For Pediatric HCV
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.