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Keeping Track: US FDA Approves Pfizer’s Vyndaqel, Jacobus’ Ruzurgi, But Nixes Acacia’s Barhemsys Again

 
• By Bridget Silverman

The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track Feature image

Here's your US drug review news for week in brief: The Food and Drug Administration issued one long-awaited approval – for Pfizer Inc.’s tafamidis products Vyndaqel and Vyndamax – and one under-the-radar application, for Ruzurgi, an amifampridine product from Jacobus Pharmaceutical Company. Acacia Pharma Ltd. was not so lucky, receiving a second complete response letter for the anti-emetic Barhemsys.

Submissions clustered around new formulations and combinations, thanks to RedHill Biopharma Ltd.’s three-drug combo for Helicobacter pylori infection, Takeda Pharmaceutical Co. Ltd

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