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ARTICLE | Market Access

How a narrow FDA label could smooth rezafungin’s launch

Cidara’s antifungal has backing of FDA panel for a limited use indication that homes in on the unmet need

February 14, 2023 12:58 AM UTC

Cidara Therapeutics is betting that when it comes to commercializing antimicrobials, less can be more. An FDA advisory committee’s endorsement of the company’s antifungal rezafungin for a limited population could help overcome hospitals’ fears that it will be a budget-buster.

FDA’s Antimicrobial Drugs Advisory Committee (ADAC) recommended approval of rezafungin on Jan. 24, voting 14-1 that the antifungal’s overall benefit-risk assessment was favorable to treat candidemia/invasive candidiasis in adults with limited or no alternative treatment options. ...

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Cidara Therapeutics Inc.