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Keeping Track: Myovant, Almirall, MacroGenics Nab Novel Approvals; Novartis’ Inclisiran Delayed

 
• By Bridget Silverman

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

Keeping Track Feature image

The agency approved a trio of novel agents over the past week, bringing the 2020 count for US FDA Center for Drug Evaluation and Research novel approvals to 51. The number of novel agents that failed to gain approval this year also grew, to 13, thanks to a complete response letter for Novartis AG’s blockbuster hopeful inclisiran for primary hyperlipidemia.

The novel agents include two cancer therapies, Myovant Sciences Ltd.’s Orgovyx and MacroGenics, Inc.’s Margenza, and Almirall SA’s Klysiri, which treats a pre-cancerous condition.

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