Keeping Track: Jardiance Approved Across Heart Failure Spectrum, But US FDA Turns Down Bardoxolone, Terlipressin

 
• By Bridget Silverman
  
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

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The US FDA’s high-profile approval of a broad, breakthrough-designated heart failure indication for Eli Lilly and Company/Boehringer Ingelheim GmbH’s Jardiance was a ray of sunshine in a week dominated by bad news, from complete response letters for Mallinckrodt plc’s terlipressin and Reata Pharmaceuticals, Inc.’s bardoxolone to a refuse-to-file letter for Allarity Therapeutics A/S’s dovitinib and delays in the FDA reviews of United Therapeutics Corporation/MannKind Corporation’s Tyvaso DPI and Rhythm Pharmaceuticals, Inc.’s Imcivree.

Provention Bio, Inc., however, looked to the future in disclosing its plans, in agreement with FDA, for the resubmission...

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