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Cidara Therapeutics, Inc.

https://www.cidara.com/

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Cidara’s Novel Antifungal Approved For Antimicrobial-Resistant C. Auris Infections

Cidara’s US commercial partner Melinta will launch the novel echinocandin this summer, announcing pricing shortly before rollout. Limited indication follows recommendation of FDA advisory panel.

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Inside US FDA’s Return To In-Person Meetings

In an interview, OND Deputy Director of Operations Kevin Bugin describes how FDA might be able to "accelerate" the transition back to in-person meetings if the initial phase with Type A and BPD Type 1 meetings goes well. But there is still no plan to return to in-person advisory committees.

Advisory Committees Coronavirus COVID-19

Rezafungin Review Highlights US FDA’s ‘Flexible Development' Approach For Antimicrobials

Cidara developed the antifungal for candidemia/invasive candidiasis pursuant to the FDA’s 2017 ‘Unmet Need guidance,’ which provides an avenue for approval with a 'limited use' indication based on a streamlined development program. Some of the guidance recommendations also have been leveraged under the LPAD pathway.

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